FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT
K Number: K954603
·
Decision Jan 4, 1996
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
11
Review Days
92
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Basic Information
- Device Name
- DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT
- K Number
- K954603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wesley Jessen Corp.
- Date Received
- October 4, 1995
- Decision Date
- January 4, 1996
- 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 Wesley Jessen Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K994335 | PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS | Mar 20, 2000 | Substantially Equivalent |
| K000439 | DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C | Mar 20, 2000 | Substantially Equivalent |
| K993935 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI | Dec 21, 1999 | Substantially Equivalent |
| K991000 | GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES | Jun 28, 1999 | Substantially Equivalent |
| K991550 | FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS | May 14, 1999 | Substantially Equivalent |
| K982988 | PRECISION UV (VASURFILCON A) | Jan 6, 1999 | Substantially Equivalent |
| K982344 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS | Dec 22, 1998 | Substantially Equivalent |
| K965052 | D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES | May 14, 1997 | Substantially Equivalent |
| K962957 | RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT | Oct 1, 1996 | Substantially Equivalent |
| K872973 | W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION | Oct 15, 1987 | Substantially Equivalent |