The following data is part of a premarket notification filed by Dorniermedtech America, Inc with the FDA for Dornier Thulio.
| Device ID | K213252 |
| 510k Number | K213252 |
| Device Name: | Dornier Thulio |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DornierMedTech America, Inc 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer DornierMedTech America, Inc 1155 Roberts Blvd, Suite 100 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 | 2021-09-30 |
| Decision Date | 2022-07-27 |