The following data is part of a premarket notification filed by Spectragenics, Inc. with the FDA for Spectra Hair Removal Laser.
| Device ID | K053527 |
| 510k Number | K053527 |
| Device Name: | SPECTRA HAIR REMOVAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRAGENICS, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan SPECTRAGENICS, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2008-02-01 |
| Summary: | summary |