iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses— 510(k) K183200
Substantially EquivalentC&E GP Specialist, Inc.
FDA 510(k) clearance K183200 for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses, Substantially Equivalent on 2019-01-09. Applicant: C&E GP Specialist, Inc.. Device class: 2.
Clearance details
- Applicant
- C&E GP Specialist, Inc.
- 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
- San Diego, CA, US
Recent devices under product code MUW
view all- 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.