The following data is part of a premarket notification filed by Luma Therapeutics with the FDA for Luma Light System.
| Device ID | K173436 |
| 510k Number | K173436 |
| Device Name: | Luma Light System |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Luma Therapeutics 10 Rollins Rd Suite 120 Millbrae, CA 94030 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer Luma Therapeutics 10 Rollins Rd Suite 120 Millbrae, CA 94030 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-03 |
| Decision Date | 2018-01-30 |
| Summary: | summary |