FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT
K Number: K003789
·
Decision Feb 21, 2001
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
12
Review Days
75
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Basic Information
- Device Name
- SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT
- K Number
- K003789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Specialty Ultravision, Inc.
- Date Received
- December 8, 2000
- Decision Date
- February 21, 2001
- 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 Specialty Ultravision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011542 | SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) | Jun 26, 2001 | Substantially Equivalent |
| K011089 | SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C | May 23, 2001 | Substantially Equivalent |
| K003526 | SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) | Feb 12, 2001 | Substantially Equivalent |
| K000376 | SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT | Mar 21, 2000 | Substantially Equivalent |
| K993580 | SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | Feb 2, 2000 | Substantially Equivalent |
| K992787 | EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR | Feb 2, 2000 | Substantially Equivalent |
| K984090 | SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) | Jul 7, 1999 | Substantially Equivalent |
| K980197 | ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR | Aug 4, 1998 | Substantially Equivalent |
| K973192 | FLEXLENS, FLEXLENS TORIC | Nov 20, 1997 | Substantially Equivalent |
| K963764 | SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR | Jan 30, 1997 | Substantially Equivalent |