METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR— 510(k) K980218
Substantially EquivalentBiocompatibles Eyewear, Inc.
FDA 510(k) clearance K980218 for METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, Substantially Equivalent on 1998-03-23. Applicant: Biocompatibles Eyewear, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocompatibles Eyewear, Inc.
- Product code
- Code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norfolk, VA, US
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- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
More clearances from Biocompatibles Eyewear, Inc.
view allAdverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.