PicoStar
Powered Laser Surgical Instrument
Asclepion Laser Technologies GmbH
The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Picostar.
Pre-market Notification Details
| Device ID | K213889 |
| 510k Number | K213889 |
| Device Name: | PicoStar |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Asclepion Laser Technologies GmbH Bruesseler Strasse 10 Jena, DE 07747 |
| Contact | Carolin Kuehling |
| Correspondent | Carolin Kuehling Asclepion Laser Technologies GmbH Bruesseler Strasse 10 Jena, DE 07747 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-04-22 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058784001078 | K213889 | 000 |
| 04058784000989 | K213889 | 000 |
Trademark Results [PicoStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PICOSTAR 75978480 not registered Dead/Abandoned |
PicoStar, LLC 1997-12-31 |
 PICOSTAR 75683918 2696915 Dead/Cancelled |
LaVision GmbH 1999-04-16 |
 PICOSTAR 75412699 2327721 Dead/Cancelled |
PicoStar, LLC 1997-12-31 |
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