The following data is part of a premarket notification filed by Sharplight Technologies Ltd. with the FDA for Dermatological Treatment Device Family.
| Device ID | K111303 |
| 510k Number | K111303 |
| Device Name: | DERMATOLOGICAL TREATMENT DEVICE FAMILY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHARPLIGHT TECHNOLOGIES LTD. P.O. BOX 4262 Zichron Yaacov, IL 30900 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon SHARPLIGHT TECHNOLOGIES LTD. P.O. BOX 4262 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 | 2011-05-09 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110240042 | K111303 | 000 |
| 07290110240035 | K111303 | 000 |