The following data is part of a premarket notification filed by Skylit Medical with the FDA for Skylit Phototherapy System.
| Device ID | K170489 |
| 510k Number | K170489 |
| Device Name: | Skylit Phototherapy System |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Skylit Medical 4225 Executive Square, Suite 420 La Jolla, CA 92037 |
| Contact | Martyn Gross |
| Correspondent | Don Canal Skylit Medical 401 North A Street Suite 775 San Diego, CA 92101 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865522000408 | K170489 | 000 |
| 00865522000415 | K170489 | 000 |