The following data is part of a premarket notification filed by Azena Medical, Llc with the FDA for Gemini 810+980 Soft Tissue Laser.
| Device ID | K192617 |
| 510k Number | K192617 |
| Device Name: | Gemini 810+980 Soft Tissue Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Azena Medical, LLC 3021 Citrus Circle Ste 180 Walnut Creek, CA 94598 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton Azena Medical, LLC 3021 Citrus Circle Ste 180 Walnut Creek, CA 94598 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2020-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861407000389 | K192617 | 000 |
| 00861407000334 | K192617 | 000 |
| 00861407000327 | K192617 | 000 |
| 00861407000310 | K192617 | 000 |