The following data is part of a premarket notification filed by Zap Lasers, Llc with the FDA for Styla Microlaser And Stylaortho.
| Device ID | K081214 |
| 510k Number | K081214 |
| Device Name: | STYLA MICROLASER AND STYLAORTHO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZAP LASERS, LLC 2621 PLEASANT HILL RD. Pleasant Hill, CA 94523 |
| Contact | Jay Goble |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-30 |
| Decision Date | 2008-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813ZLR30080 | K081214 | 000 |
| D813BLSR1012A1 | K081214 | 000 |
| D813BLSR1013A1 | K081214 | 000 |
| D813BLSR30030 | K081214 | 000 |
| D813BLSR30080 | K081214 | 000 |
| D813ZLR10010 | K081214 | 000 |
| D813ZLR1001L0 | K081214 | 000 |
| D813ZLR1001R0 | K081214 | 000 |
| D813ZLR10060 | K081214 | 000 |
| D813ZLR10080 | K081214 | 000 |
| D813ZLR1012A1 | K081214 | 000 |
| D813ZLR1013A1 | K081214 | 000 |
| D813ZLR30030 | K081214 | 000 |
| D813ZLR3003L0 | K081214 | 000 |
| D813ZLR30060 | K081214 | 000 |
| D813BLSR3003L0 | K081214 | 000 |