COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS— 510(k) K990264
Substantially EquivalentMetro Optics of Austin, Inc.
FDA 510(k) clearance K990264 for COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS, Substantially Equivalent on 1999-03-31. Applicant: Metro Optics of Austin, Inc.. Device class: 2.
Clearance details
- Applicant
- Metro Optics of Austin, Inc.
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pflugerville, TX, US
Recent devices under product code HQD
view all- K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
- K241571 — BostonSight® Specialty Lenses
- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more
More clearances from Metro Optics of Austin, Inc.
view all- K233221 — Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
- K100244 — METRO SOFT
- K080512 — REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
- K031532 — SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR
- K001620 — METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.