The following data is part of a premarket notification filed by Theradome Inc. with the FDA for Theradome Lh80 Pro.
| Device ID | K171775 |
| 510k Number | K171775 |
| Device Name: | Theradome LH80 PRO |
| Classification | Laser, Comb, Hair |
| Applicant | Theradome Inc. 4900 Hopyard Rd, Ste 100 Pleasanton, CA 94588 |
| Contact | Tamim Hamid |
| Correspondent | Tamim Hamid Theradome Inc. 4900 Hopyard Rd, Ste 100 Pleasanton, CA 94588 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-14 |
| Decision Date | 2018-01-09 |
| Summary: | summary |