The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Medilas H Laser Fibers.
| Device ID | K123385 |
| 510k Number | K123385 |
| Device Name: | MEDILAS H LASER FIBERS |
| 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 | 2012-11-02 |
| Decision Date | 2012-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810116020430 | K123385 | 000 |
| 10810116023476 | K123385 | 000 |
| 10810116023469 | K123385 | 000 |
| 10810116023445 | K123385 | 000 |
| 10810116023186 | K123385 | 000 |
| 10810116023179 | K123385 | 000 |
| 10810116023162 | K123385 | 000 |
| 10810116023155 | K123385 | 000 |
| 10810116023148 | K123385 | 000 |
| 04049958003820 | K123385 | 000 |
| 04049958003813 | K123385 | 000 |
| 04049958003806 | K123385 | 000 |
| 04049958003783 | K123385 | 000 |
| 04049958002700 | K123385 | 000 |
| 04049958002694 | K123385 | 000 |
| 04049958002687 | K123385 | 000 |
| 04049958002731 | K123385 | 000 |
| 10810116023483 | K123385 | 000 |
| 10810116023490 | K123385 | 000 |
| 00810116020423 | K123385 | 000 |
| 00810116020461 | K123385 | 000 |
| 00810116020409 | K123385 | 000 |
| 00810116020393 | K123385 | 000 |
| 00810116020232 | K123385 | 000 |
| 00810116020089 | K123385 | 000 |
| 00810116020096 | K123385 | 000 |
| 00810116020102 | K123385 | 000 |
| 00810116020119 | K123385 | 000 |
| 00810116021123 | K123385 | 000 |
| 00810116021116 | K123385 | 000 |
| 00810116021109 | K123385 | 000 |
| 00810116021093 | K123385 | 000 |
| 00810116021086 | K123385 | 000 |
| 10810116023452 | K123385 | 000 |
| 10810116023506 | K123385 | 000 |
| 04049958002670 | K123385 | 000 |