The following data is part of a premarket notification filed by Freedom Laser Therapy, Inc. with the FDA for Irestore Professional 282.
| Device ID | K183417 |
| 510k Number | K183417 |
| Device Name: | IRestore Professional 282 |
| Classification | Laser, Comb, Hair |
| Applicant | Freedom Laser Therapy, Inc. 16782 Von Karman Avenue, Unit #15 Irvine, CA 92606 |
| Contact | Craig Nabat |
| Correspondent | Raymond R. Blanche NST Consultants, Inc. 641 Shunpike Road, Suite 311 Chatham, NJ 07928 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-10 |
| Decision Date | 2019-05-17 |
| Summary: | summary |