The following data is part of a premarket notification filed by Harpar Grace International with the FDA for Shani Darden Led Light Therapy Mask.
| Device ID | K214103 |
| 510k Number | K214103 |
| Device Name: | Shani Darden LED Light Therapy Mask |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Harpar Grace International Unit 4 Imperial Court, Magellan Close, Walworth Business Park, Hampshire Andover, GB Sp10 5nt |
| Contact | Alana Marie Chalmers |
| Correspondent | Susan D'arcy iSMART Developments Ltd 129 Green Lanes, Sutton Coldfield Birmingham, GB B735tr |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-29 |
| Decision Date | 2022-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060534510517 | K214103 | 000 |
| 05060534510401 | K214103 | 000 |