The following data is part of a premarket notification filed by Dornier Medtech America with the FDA for Dornier Medilas H Solvo 35 Laser.
| Device ID | K180350 |
| 510k Number | K180350 |
| Device Name: | Dornier Medilas H Solvo 35 Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Dornier MedTech America 1155 Roberts Blvd Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America 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 | 2018-02-08 |
| Decision Date | 2018-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049958004032 | K180350 | 000 |
| 04049958004025 | K180350 | 000 |