The following data is part of a premarket notification filed by Dermal Photonics Corporation with the FDA for Nira Beauty Skin Laser.
| Device ID | K163137 |
| 510k Number | K163137 |
| Device Name: | NIRA Beauty Skin Laser |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Dermal Photonics Corporation 5 Elm St, Suite 10 Danvers, MA 01923 |
| Contact | David Bean |
| Correspondent | David Bean Dermal Photonics Corporation 5 Elm St, Suite 10 Danvers, MA 01923 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-09 |
| Decision Date | 2017-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860296000142 | K163137 | 000 |
| 00850020752126 | K163137 | 000 |