The following data is part of a premarket notification filed by Photonmd, Inc with the FDA for Revian Red.
| Device ID | K173729 |
| 510k Number | K173729 |
| Device Name: | REVIAN RED |
| Classification | Laser, Comb, Hair |
| Applicant | PhotonMD, Inc 627 Davis Drive, Suite 400 Morrisville, NC 27560 |
| Contact | William A Knape |
| Correspondent | William A Knape PhotonMD, Inc 627 Davis Drive, Suite 400 Morrisville, NC 27560 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-06 |
| Decision Date | 2018-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862712000309 | K173729 | 000 |
| 00850003374017 | K173729 | 000 |
| 00850003374147 | K173729 | 000 |
| 00850003374116 | K173729 | 000 |
| 00850003374093 | K173729 | 000 |
| 00850003374109 | K173729 | 000 |
| 00850003374130 | K173729 | 000 |
| 00862712000316 | K173729 | 000 |
| 00862712000378 | K173729 | 000 |
| 00850003374161 | K173729 | 000 |