The following data is part of a premarket notification filed by Active Optical Systems, Ltd./efraim Bidas with the FDA for Models Crystal 512, Record 618, Optima 518 Photo Epilation Systems.
| Device ID | K050950 |
| 510k Number | K050950 |
| Device Name: | MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS 24 HERZEL ST. Petach Tikva, IL 49591 |
| Contact | Efraim Bidas |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2005-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016727081 | K050950 | 000 |
| 07290016727067 | K050950 | 000 |
| 07290016727050 | K050950 | 000 |
| 07290016727043 | K050950 | 000 |