Easyret
Laser, Ophthalmic
Quantel Medical
The following data is part of a premarket notification filed by Quantel Medical with the FDA for Easyret.
Pre-market Notification Details
| Device ID | K170067 |
| 510k Number | K170067 |
| Device Name: | Easyret |
| Classification | Laser, Ophthalmic |
| Applicant | Quantel Medical 11 Rue Bois Joli, CS40015 Cournon D'auvergne-cedex, FR 63808 |
| Contact | Bruno Pages |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700542625484 | K170067 | 000 |
| 03700542625927 | K170067 | 000 |
Trademark Results [Easyret]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EASYRET 79196611 5215829 Live/Registered |
QUANTEL MEDICAL 2016-07-18 |
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