QMM — Hydrophilic Re-Coating Solution Class II
FDA product code QMM covers "Hydrophilic Re-Coating Solution", a Class II medical device regulated under 21 CFR 886.5919. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QMM
- Device Class
- Class II
- Regulation Number
- 886.5919
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200002 | tangible science | Tangible Boost | September 24, 2020 |