FDA Registration Active 🇩🇪 Germany

Asclepion Laser Technologies GmbH

Reg #: 3004485166 · FEI: 3004485166 · Expires 2026
Products
2
Proprietary Names
20
Establishment Types
3
Classifications
2

Registration Details

Registration Name
Asclepion Laser Technologies GmbH
Registration Number
3004485166
FEI Number
3004485166
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Bruesseler Str. 10
City
Jena Thuringia
Country
DE

Regulatory Submissions

510(k) Number
K261094

Owner / Operator

Firm Name
Asclepion Laser Technologies GmbH
Operator Number
10023622
Address
Bruesseler Str. 10
City
Jena
State
Thuringia
Postal Code
07747
Country
DE
Correspondent
Tom Gruender

US Agent

Business Name
Emergo Global Representation LLC
Contact Name
Yong Sun
Address
2500 Bee Cave Rd., Bldg. 1, Ste. 300
City
Austin
State
TX
ZIP
78746
Country
US
Phone
512 3279997

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX
Laparoscope, General & Plastic Surgery GCJ

Proprietary Names

YellowStar MultiPulse PRO 60 MultiPulse PRO DUO Nanostar R Nanostar C Nanostar Y AlexStar MeDioStar OMNI QuadroStarPRO MultiPulse Ho MultiPulse HoPLUS Dermablate Juliet MCL 31 Dermablate MultiPulse TM+1470 TattooStar R PicoStar MultiCut Solo MultiPulse TFL

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device