FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
K Number: K982947
·
Decision Jan 29, 1999
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
7
Review Days
161
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Basic Information
- Device Name
- BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS
- K Number
- K982947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ocular Sciences Puerto Rico, Inc.
- Date Received
- August 21, 1998
- Decision Date
- January 29, 1999
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Ocular Sciences Puerto Rico, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013377 | BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Dec 20, 2001 | Substantially Equivalent |
| K012425 | BIOMEDICS UV MULTIFOCAL | Oct 12, 2001 | Substantially Equivalent |
| K003136 | OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Jan 6, 2001 | Substantially Equivalent |
| K992264 | OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS | Nov 24, 1999 | Substantially Equivalent |
| K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | Jan 21, 1999 | Substantially Equivalent |
| K972303 | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS | Aug 20, 1997 | Substantially Equivalent |