The following data is part of a premarket notification filed by Sharplight Technologies Ltd. with the FDA for Beamax/ Formax Pulsed Light Device Family.
| Device ID | K082876 |
| 510k Number | K082876 |
| Device Name: | BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLIGHT TECHNOLOGIES LTD. 29B BEN GURION ST. Zichron Yaacov, IL 30900 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon SHARPLIGHT TECHNOLOGIES LTD. 29B BEN GURION ST. Zichron Yaacov, IL 30900 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2008-11-10 |
| Summary: | summary |