Capsulo
Laser, Ophthalmic
Quantel Medical
The following data is part of a premarket notification filed by Quantel Medical with the FDA for Capsulo.
Pre-market Notification Details
| Device ID | K220430 |
| 510k Number | K220430 |
| Device Name: | Capsulo |
| Classification | Laser, Ophthalmic |
| Applicant | Quantel Medical 1 Rue Du Bois Joli-CS40015 Cournon D'Auvergne-Cedex, FR 63808 |
| Contact | Bruno Pages |
| Correspondent | Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-15 |
| Decision Date | 2022-05-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700542625958 | K220430 | 000 |
Trademark Results [Capsulo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSULO 79325151 not registered Live/Pending |
QUANTEL MEDICAL 2021-09-23 |
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