The following data is part of a premarket notification filed by Mz Skin with the FDA for Mz Skin Lightmax Supercharged Led Mask 2.0.
| Device ID | K213184 |
| 510k Number | K213184 |
| Device Name: | MZ Skin LightMAX Supercharged LED Mask 2.0 |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Mz Skin 110-112 Kings Road, First Floor London, GB Sw3 4tx |
| Contact | Maryam Zamani |
| 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 | 2021-09-29 |
| Decision Date | 2021-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060534510418 | K213184 | 000 |