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 |