The following data is part of a premarket notification filed by Paradigm Lasers, Inc. with the FDA for Paraderm -585m Dermatological Laser.
| Device ID | K941559 |
| 510k Number | K941559 |
| Device Name: | PARADERM -585M DERMATOLOGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PARADIGM LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan PARADIGM LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-11-03 |