The following data is part of a premarket notification filed by Gme German Medical Engineering Gmbh with the FDA for Twinscan 808/755 Laser System.
| Device ID | K192269 |
| 510k Number | K192269 |
| Device Name: | TwinScan 808/755 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GME German Medical Engineering GmbH Grimmstrasse 23 Nuremberg, DE 90491 |
| Contact | Stefan Schulze |
| Correspondent | Mike Johnson Philosopher's River LLC P O Box 106 Willow Creek, MT 59760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2019-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B12510600 | K192269 | 000 |