The following data is part of a premarket notification filed by Freedom Laser Therapy, Inc. with the FDA for Id-510 Irestore Elite.
| Device ID | K222081 |
| 510k Number | K222081 |
| Device Name: | ID-510 IRestore Elite |
| Classification | Laser, Comb, Hair |
| Applicant | Freedom Laser Therapy, Inc. 16782 Von Karman Avenue, Unit 15 Irvine, CA 92606 |
| Contact | Wei-Chih Chen |
| Correspondent | Sharon Chen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-10-13 |