OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K020193
Substantially EquivalentCl Mcintosh
FDA 510(k) clearance K020193 for OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2002-02-28. Applicant: Cl Mcintosh. Device class: 2.
Clearance details
- Applicant
- Cl Mcintosh
- 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
- Abbreviated
- Location
- Rockville, MD, US
Recent devices under product code LPL
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- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
Adverse 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.