The following data is part of a premarket notification filed by Allmed Systems Inc. with the FDA for Revolix Duo Laser System.
| Device ID | K070466 |
| 510k Number | K070466 |
| Device Name: | REVOLIX DUO LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALLMED SYSTEMS INC. 9232 KLEMETSON DRIVE Pleasanton, CA 94588 |
| Contact | Peter Allen |
| Correspondent | Peter Allen ALLMED SYSTEMS INC. 9232 KLEMETSON DRIVE Pleasanton, CA 94588 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-04-17 |
| Summary: | summary |