The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Medilas D Family Lasers, Including Medilas D Litebeam, Litebeam +, Urobeam, Multibeam, Flexipulse And Magnapulse.
| Device ID | K083500 |
| 510k Number | K083500 |
| Device Name: | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Theron Gober |
| Correspondent | Theron Gober 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 | 2008-11-25 |
| Decision Date | 2009-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810116022595 | K083500 | 000 |
| 00810116022717 | K083500 | 000 |
| 00810116022731 | K083500 | 000 |
| 00810116022618 | K083500 | 000 |
| 00810116022656 | K083500 | 000 |
| 00810116022670 | K083500 | 000 |
| 00810116022694 | K083500 | 000 |
| 00810116022755 | K083500 | 000 |
| 00810116022779 | K083500 | 000 |
| 00810116022397 | K083500 | 000 |
| 00810116022410 | K083500 | 000 |
| 00810116022434 | K083500 | 000 |
| 00810116022441 | K083500 | 000 |
| 00810116022533 | K083500 | 000 |
| 00810116022557 | K083500 | 000 |
| 00810116022564 | K083500 | 000 |
| 00810116022632 | K083500 | 000 |