The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Lasertx - Diode Laser & Delivery System.
| Device ID | K060326 |
| 510k Number | K060326 |
| Device Name: | LASERTX - DIODE LASER & DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-04-05 |