The following data is part of a premarket notification filed by Norlase with the FDA for Echo Photocoagulator.
| Device ID | K222157 |
| 510k Number | K222157 |
| Device Name: | ECHO Photocoagulator |
| Classification | Laser, Ophthalmic |
| Applicant | Norlase Brydehusvej 13 Ballerup, DK DK-2750 |
| Contact | Jan Forstberg |
| Correspondent | Jan Forstberg Norlase Brydehusvej 13 Ballerup, DK DK-2750 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-20 |
| Decision Date | 2022-10-11 |