The following data is part of a premarket notification filed by Azena Medical, Llc with the FDA for Gemini 2 810+980 Soft Tissue Laser.
| Device ID | K210350 |
| 510k Number | K210350 |
| Device Name: | Gemini 2 810+980 Soft Tissue Laser |
| Classification | Laser, Dental, Soft Tissue |
| Applicant | Azena Medical, LLC 3021 Citrus Circle Suite 180 Walnut Creek, CA 94598 |
| Contact | Lindsay Tilton |
| Correspondent | Lindsay Tilton Azena Medical, LLC 3021 Citrus Circle Suite 180 Walnut Creek, CA 94598 |
| Product Code | NVK |
| Subsequent Product Code | GEX |
| Subsequent Product Code | ILY |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850010501086 | K210350 | 000 |
| 00850010501079 | K210350 | 000 |
| 00850010501062 | K210350 | 000 |
| 00850010501130 | K210350 | 000 |
| 00850010501123 | K210350 | 000 |
| 00850010501116 | K210350 | 000 |
| 00850010501109 | K210350 | 000 |
| 00850010501093 | K210350 | 000 |