The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Medilas D Family Lasers.
| Device ID | K070536 |
| 510k Number | K070536 |
| Device Name: | MEDILAS D FAMILY LASERS |
| 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 | 2007-02-26 |
| Decision Date | 2007-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049958001383 | K070536 | 000 |
| 04049958001307 | K070536 | 000 |
| 04049958000225 | K070536 | 000 |
| 04049958000218 | K070536 | 000 |