MUW — Lens, Contact (Orthokeratology) Class II
FDA product code MUW covers "Lens, Contact (Orthokeratology)", a Class II medical device regulated under 21 CFR 886.5916. Submissions are reviewed by the Ophthalmic panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUW
- Device Class
- Class II
- Regulation Number
- 886.5916
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183200 | c and e gp specialist | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | January 9, 2019 |
| K160859 | contamac | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | July 13, 2016 |
| K010109 | paragon vision sciences | FLUOROPERM 151-OK, PARAGON HDS 100-OK | February 28, 2001 |
| K003933 | polymer technology | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | February 16, 2001 |
| K000224 | paragon vision sciences | FLUROPERM 60-OK, PARAGON HDS-OK | April 17, 2000 |
| K973697 | airperm | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTH | April 8, 1998 |