The following data is part of a premarket notification filed by Omm Imports, Inc. D/b/a Zero Gravity with the FDA for Sapphire, Elevare Sapphire.
| Device ID | K172555 |
| 510k Number | K172555 |
| Device Name: | SAPPHIRE, ELEVARE SAPPHIRE |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Omm Imports, Inc. D/b/a Zero Gravity 9737 NW 41St Street Doral, FL 33178 |
| Contact | Zivan Habibi |
| Correspondent | Susan Anthoney-dewet Aegis, Inc 2424 Dempster Drive Coralville, IA 52241 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-24 |
| Decision Date | 2018-05-01 |
| Summary: | summary |