The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Medilas H Rfid Laser Fiber.
| Device ID | K121938 |
| 510k Number | K121938 |
| Device Name: | MEDILAS H RFID LASER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810116020300 | K121938 | 000 |
| 00810116020522 | K121938 | 000 |
| 10810116023322 | K121938 | 000 |
| 10810116023315 | K121938 | 000 |
| 10810116023308 | K121938 | 000 |
| 10810116023292 | K121938 | 000 |
| 10810116023285 | K121938 | 000 |
| 10810116023261 | K121938 | 000 |
| 04049958002663 | K121938 | 000 |
| 04049958002656 | K121938 | 000 |
| 04049958002717 | K121938 | 000 |
| 04049958002649 | K121938 | 000 |
| 00810116020539 | K121938 | 000 |
| 00810116020737 | K121938 | 000 |
| 00810116020744 | K121938 | 000 |
| 00810116020294 | K121938 | 000 |
| 00810116020287 | K121938 | 000 |
| 00810116020270 | K121938 | 000 |
| 00810116020225 | K121938 | 000 |
| 00810116020126 | K121938 | 000 |
| 00810116020027 | K121938 | 000 |
| 00810116020140 | K121938 | 000 |
| 00810116020157 | K121938 | 000 |
| 00810116020836 | K121938 | 000 |
| 00810116020829 | K121938 | 000 |
| 00810116020812 | K121938 | 000 |
| 04049958002632 | K121938 | 000 |