The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Flash N' Go.
| Device ID | K082298 |
| 510k Number | K082298 |
| Device Name: | FLASH N' GO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOME SKINOVATIONS LTD. APOLO BUILDING POB 533 Yokneam, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman HOME SKINOVATIONS LTD. APOLO BUILDING POB 533 Yokneam, IL 20692 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-12 |
| Decision Date | 2008-10-23 |
| Summary: | summary |