Executive Department of Medical

‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

Issuing Date: 30/12/2019 Authorization Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 Version Number: 8 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 02/8/1443 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

The Authorization is issued in accordance with the Medical ‫أﺻﺪر ﻫﺬا اﻹذن ﺑﻤﻮﺟﺐ ﻧﻈﺎم اﻷﺟﻬﺰة واﻟﻤﺴﺘﻠﺰﻣﺎت اﻟﻄﺒ ﻴﺔ اﻟﺼﺎدر‬
Devices Law issued by Royal Decree No. (M/54 ) dated .‫ ﻫـ‬6/7/1442 ‫ ( وﺗﺎر ﻳﺦ‬54/‫ﺑﺎﻟﻤﺮﺳﻮم اﻟﻤﻠﻜﻲ رﻗﻢ )م‬
6/7/14 4 2 HA,

This authorization allows:

ME0000013275 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

fotona d.o.o
stenge 7,,Ljubjana,1000 Slovenia

To market the medical devices listed in the attached annex* *‫ اﻟﻤﺴﺘﻠﺰﻣﺎت اﻟﻄﺒ ﻴﺔ اﻟﻤﺤﺪدة ﻓﻲ اﻟﻘﺎﺋﻤﺔ اﻟﻤﺮﻓﻘﺔ‬/ ‫ﺑﺘﺴﻮ ﻳﻖ اﻷﺟﻬﺰة‬
in the Kingdom of Saudi Arabia ‫ﻓﻲ اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑ ﻴﺔ اﻟﺴﻌﻮد ﻳﺔ‬

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 1 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎ ز‬
Annex of Medical Device Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬
‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade
P ro duct Descrip tio n Medical Natio nal Listing No .
Name

1 XS Dynamis Medical laser For dermatology and surgery . ME0000013288SFDAA00001

Q-switched medical laser Nd:YAG with a wavelengths of 1064, 532, 585 and 650
2 Fotona QX Max ME0000013288SFDAA00008
nm.

3 XP Dynamis Medical laser For applications in dermatology and surgery ME0000013288SFDAA00009

4 LIGHTWALKER AT Medical laser For applications in dentistry, dermatology and surgery ME0000013288SFDAA00013

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 2 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎ ز‬
Annex of Medical Device Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

5 Dualis SP II Medical laser For dermatology, and surgery ME0000013288SFDAA00010

6 Fotona XP Max Medical laser For dermatology and surgery ME0000013288SFDAA00011

7 Dualis XS Medical laser For applications in dermatology and surgery ME0000013288SFDAA00012

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 3 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

1 FS01 Hand piece A1ME0000013288SFDAA00001

2 PS02 hand piece A2ME0000013288SFDAA00001

3 R11 hand piece A3ME0000013288SFDAA00001

4 PS03 hand piece A4ME0000013288SFDAA00001

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 4 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

5 R28 , with 2 – 8 mm variable spot sizes A1ME0000013288SFDAA00008

6 R33-T Nd:YAG hand piece A1ME0000013288SFDAA00009

7 R34-T Nd:YAG handpiece A2ME0000013288SFDAA00009

8 S11 scanner High speed scanner A3ME0000013288SFDAA00009

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 5 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

9 L-Runner High speed scanner A4ME0000013288SFDAA00009

10 PS02 Dearmatological handpiece A1ME0000013288SFDAA00010

11 R11 Dermatological handpiece A2ME0000013288SFDAA00010

12 R33-T Nd:YAG handpiece A3ME0000013288SFDAA00010

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 6 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

13 R34-T Nd:YAG handpiece A4ME0000013288SFDAA00010

14 S11 scanner High speed scanner A5ME0000013288SFDAA00010

15 R33-T Nd:YAG handpiece A1ME0000013288SFDAA00011

16 R34-T Nd:YAG handpiece A2ME0000013288SFDAA00011

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 7 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

17 S11 scanner High speed scanner A3ME0000013288SFDAA00011

18 R11 Dermatological handpiece A1ME0000013288SFDAA00012

19 PS02 Dearmatological handpiece A2ME0000013288SFDAA00012

20 R21-C2 Dental hand piece A1ME0000013288SFDAA00013

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 8 of 9
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ ﻣ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices Sector

‫ ﻣ ﺴ ﺘ ﻠ ﺰ م ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorization

‫ ﻣ ﺴ ﺘ ﻠﺰ م ﻃ ﺒ ﻲ‬/ ‫ﻗ ﺎ ﺋ ﻤ ﺔ ﻣﺮ ﻓ ﻘ ﺔ ﺑ ﺈ ذ ن ﺗ ﺴ ﻮ ﻳ ﻖ ﻣ ﻠ ﺤ ﻘ ﺎ ت ﺟ ﻬ ﺎ ز‬
Annex of Accessories Marketing Authorization

Issuing Date: 30/12/2019 Annex Number: MDMA-1-2019-6229 :‫ر ﻗ ﻢ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 04/5/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 26/5/2024 No. of Annex Pages: 9 :‫ﻋ ﺪ د ﺻ ﻔ ﺤ ﺔ ا ﻟ ﻤﺮ ﻓ ﻖ‬ 19/11/1445 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬
Last Version Date: 05/3/2022 05/3/2022 :‫ﺗ ﺎ ر ﻳ ﺦ أ ﺧﺮ إ ﺻ ﺪ ا ر‬

This annex is an integral part of the Medical Devices ‫ ﻣﺴﺘﻠﺰم ﻃﺒﻲ‬/ ‫ﻳﻌﺪ ﻫﺬا اﻟﻤﺮﻓﻖ ﺟﺰًءا ﻣﻜﻤًﻼ ﻹذن ﺗﺴﻮ ﻳﻖ ﺟﻬﺎز‬
Marketing (MDMA-1-2 0 19 -6 2 2 9 ) ‫رﻗﻢ‬
Authorization Number (MDMA-1-2019-6229) (8 ) ‫ورﻗﻢ إﺻﺪار‬
Issuing Number (8)

: Issued to ME0000013275 : ‫ا ﺻ ﺪر ت ل‬

fotona d.o.o

stenge 7,,Ljubjana,1000 Slovenia

‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬ ‫ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﻤ ﺴ ﺘ ﻠﺰ م ا ﻟ ﻄ ﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ ا ﻟ ﻮ ﻃ ﻨ ﻲ‬
Brand / Trade Name P ro duct Descrip tio n Medical Natio nal Listing No .

21 HC14-N Dental hand piece A2ME0000013288SFDAA00013

22 HC14-NS Dental hand piece A3ME0000013288SFDAA00013

23 HC14-NE Dental hand piece A4ME0000013288SFDAA00013

24 HC02-N Dental hand piece A5ME0000013288SFDAA00013

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.
Page 9 of 9