FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K Number: K963001
·
Decision Mar 11, 1997
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
7
Review Days
221
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Basic Information
- Device Name
- LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
- K Number
- K963001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Permeable Technologies, Inc.
- Date Received
- August 2, 1996
- Decision Date
- March 11, 1997
- 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 Permeable Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963011 | LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Nov 29, 1996 | Substantially Equivalent |
| K963010 | LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Nov 20, 1996 | Substantially Equivalent |
| K951893 | LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55 (OCUFILCON D) GHYDROPHILIC CONTACT LENS | Nov 17, 1995 | Substantially Equivalent |
| K950283 | LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENS | Feb 7, 1995 | Substantially Equivalent |
| K945981 | LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS | Feb 7, 1995 | Substantially Equivalent |
| K942494 | LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS | Sep 8, 1994 | Substantially Equivalent |