OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS— 510(k) K003136
Substantially EquivalentOcular Sciences Puerto Rico, Inc.
FDA 510(k) clearance K003136 for OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS, Substantially Equivalent on 2001-01-06. Applicant: Ocular Sciences Puerto Rico, Inc.. Device class: 2.
Clearance details
- Applicant
- Ocular Sciences Puerto Rico, Inc.
- Product code
- Product 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
- Rockville, MD, US
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More clearances from Ocular Sciences Puerto Rico, Inc.
view all- K013377 — BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- K012425 — BIOMEDICS UV MULTIFOCAL
- K992264 — OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
- K982947 — BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
- K984046 — BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
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.