Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K213889 |
Device Name |
PicoStar |
Applicant |
Asclepion Laser Technologies GmbH |
Bruesseler Strasse 10 |
Jena,
DE
07747
|
|
Applicant Contact |
Carolin Kuehling |
Correspondent |
Asclepion Laser Technologies GmbH |
Bruesseler Strasse 10 |
Jena,
DE
07747
|
|
Correspondent Contact |
Carolin Kuehling |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/13/2021 |
Decision Date | 04/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|