The following data is part of a premarket notification filed by Lyma Life Ltd. with the FDA for Lyma Laser.
| Device ID | K210823 |
| 510k Number | K210823 |
| Device Name: | LYMA Laser |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | LYMA Life Ltd. 93 Gloucester Place London, GB W1h 6jq |
| Contact | Simon Goff |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | OHS |
| Subsequent Product Code | ILY |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2022-03-18 |