The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas D Skinpulse S Laser Systems.
| Device ID | K021724 |
| 510k Number | K021724 |
| Device Name: | DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-24 |
| Decision Date | 2002-08-19 |
| Summary: | summary |