BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY— 510(k) K003933
Substantially EquivalentPolymer Technology
FDA 510(k) clearance K003933 for BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY, Substantially Equivalent on 2001-02-16. Applicant: Polymer Technology. Device class: 2.
Clearance details
- Applicant
- Polymer Technology
- Product code
- Code MUW
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code MUW
view all- 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
- K000224 — FLUROPERM 60-OK, PARAGON HDS-OK
- K973697 — AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
More clearances from Polymer Technology
view allData sourced from openFDA. This site is unofficial and independent of the FDA.