The following data is part of a premarket notification filed by Theradome, Inc with the FDA for Laser Helmet Lh40-evo.
| Device ID | K161046 |
| 510k Number | K161046 |
| Device Name: | Laser Helmet LH40-EVO |
| Classification | Laser, Comb, Hair |
| Applicant | Theradome, Inc 4900 Hopyard Road, Suite 100 Pleasanton, CA 94588 |
| Contact | Tamim Hamid |
| Correspondent | Vern Liebmam Theradome, Inc 4900 Hopyard Road, Suite 100 Pleasanton, CA 94588 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-13 |
| Decision Date | 2016-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B399EVO0400 | K161046 | 000 |