The following data is part of a premarket notification filed by Genesis Biosystems, Inc. with the FDA for Genesis Led Wands.
| Device ID | K131142 |
| 510k Number | K131142 |
| Device Name: | GENESIS LED WANDS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GENESIS BIOSYSTEMS, INC. 1500 EAGLE COURT Lewisville, TX 75057 |
| Contact | Jim Lafferty |
| Correspondent | Jim Lafferty GENESIS BIOSYSTEMS, INC. 1500 EAGLE COURT Lewisville, TX 75057 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818257020081 | K131142 | 000 |
| 00818257020074 | K131142 | 000 |