The following data is part of a premarket notification filed by Dornier Surgical Products, Inc. with the FDA for Dornier Medilas D Skinpulse Laser System (skinpulse).
| Device ID | K003993 |
| 510k Number | K003993 |
| Device Name: | DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER SURGICAL PRODUCTS, INC. 10027 SOUTH 51ST ST. Phoenix, AZ 85044 -6731 |
| Contact | Walter Payerl |
| Correspondent | Walter Payerl DORNIER SURGICAL PRODUCTS, INC. 10027 SOUTH 51ST ST. Phoenix, AZ 85044 -6731 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-03-26 |