The following data is part of a premarket notification filed by Zap Lasers, Llc with the FDA for Softlase G2-surgical Diode Laser System.
| Device ID | K021227 |
| 510k Number | K021227 |
| Device Name: | SOFTLASE G2-SURGICAL DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZAP LASERS, LLC 2643 PLEASANT HILL RD. Pleasant Hill, CA 94523 |
| Contact | Jay Goble |
| Correspondent | Jay Goble ZAP LASERS, LLC 2643 PLEASANT HILL RD. Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2002-06-26 |
| Summary: | summary |