Product code MUW— Ophthalmic
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
- Classification name
- Lens, Contact (Orthokeratology)
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code MUW
FDA has cleared devices under product code MUW between 1998 and 2019, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2016
- 2001
- 2000
- 1998
Top applicants under product code MUW
Recent clearances under product code MUW
- K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
- K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
- K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK
- K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
- K000224 — FLUROPERM 60-OK, PARAGON HDS-OK
- K973697 — AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
Data sourced from openFDA. This site is unofficial and independent of the FDA.