Asclepion Laser Technologies GmbH

Address:Bruesseler Str. 10,Jena Thuringia,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

Clear

TattooStar - 04058784000132 Catalog Number :

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MCL 31 Dermablate - 04058784000224 Catalog Number :

Device Description : Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, v Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MeDioStar - 04058784000279 Catalog Number :

Device Description : Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal, permanent hair reduction and the treatment ofbenign pigmented and vascular lesions.

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber 2.1 200 - 04058784000293 Catalog Number :

Device Description : Single use optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber B 2.1 272 - 04058784000309 Catalog Number :

Device Description : Single use optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber B 2.1 365 - 04058784000316 Catalog Number :

Device Description : Single use optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber B 2.1 550 - 04058784000323 Catalog Number :

Device Description : Single use optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber R 2.1 200 - 04058784000330 Catalog Number :

Device Description : Reusable optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber B R 2.1 272 - 04058784000347 Catalog Number :

Device Description : Reusable optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Bare Fiber B R 2.1 365 - 04058784000354 Catalog Number :

Device Description : Reusable optical fiber for surgery

Device Class : 2

Duns Number: 332247852

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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