The following data is part of a premarket notification filed by Theradome, Inc. with the FDA for Theradome Lh40.
| Device ID | K180460 |
| 510k Number | K180460 |
| Device Name: | Theradome LH40 |
| Classification | Laser, Comb, Hair |
| Applicant | Theradome, Inc. 4900 Hopyard Road, Suite 100 Pleasanton, CA 94588 |
| Contact | Tamim Hamid |
| Correspondent | Jacqueline A. Hauge Jacqueline A. Hauge 23300 Manning Trail N Scandia, MN 55073 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-05-18 |
| Summary: | summary |