The following data is part of a premarket notification filed by Norlase Aps with the FDA for Leaf Photocoagulator.
| Device ID | K190083 |
| 510k Number | K190083 |
| Device Name: | Leaf Photocoagulator |
| Classification | Laser, Ophthalmic |
| Applicant | Norlase ApS Brydehusvej 302750 Ballerup, DK |
| Contact | Jan Forstberg |
| Correspondent | Sheila Pickering Sheila Pickering Consulting Group 2081 Longden Circle Los Altos, CA 94024 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-17 |
| Decision Date | 2019-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700002165411 | K190083 | 000 |
| 05700002165442 | K190083 | 000 |