The following data is part of a premarket notification filed by Omm Imports, Inc. D/b/a Zero Gravity with the FDA for Laser Hair Therapy.
| Device ID | K183329 |
| 510k Number | K183329 |
| Device Name: | Laser Hair Therapy |
| Classification | Laser, Comb, Hair |
| Applicant | OMM Imports, Inc. D/B/A Zero Gravity 1945 S Ocean Dr Apt 509 Hallandale Beach Blvd Hallandale, FL 33009 |
| Contact | Moti Shenfarber |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center Guimiao Road Shenzhen, CN 518000 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-01-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LASER HAIR THERAPY 75378812 not registered Dead/Abandoned |
Laser Hair Therapy, L.L.C 1997-10-24 |