The following data is part of a premarket notification filed by Active Optical Systems , Ltd. with the FDA for Spirit Hair Removal Laser Family.
| Device ID | K153718 |
| 510k Number | K153718 |
| Device Name: | Spirit Hair Removal Laser Family |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ACTIVE OPTICAL SYSTEMS , LTD. 11 SHOHAM ST. Petach-tikva, IL 49591 |
| Contact | Gil 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 | 2015-12-28 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016727029 | K153718 | 000 |
| 07290016727012 | K153718 | 000 |