FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
K Number: K994324
·
Decision Feb 23, 2000
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
8
Review Days
63
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Basic Information
- Device Name
- ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- K Number
- K994324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date Received
- December 22, 1999
- Decision Date
- February 23, 2000
- 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 Vistakon, Johnson & Johnson Vision Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994318 | VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Feb 23, 2000 | Substantially Equivalent |
| K991163 | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR | Jun 8, 1999 | Substantially Equivalent |
| K991134 | ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR | May 6, 1999 | Substantially Equivalent |
| K983912 | VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER | Jan 26, 1999 | Substantially Equivalent |
| K964612 | VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT | Jan 30, 1997 | Substantially Equivalent |
| K962804 | ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER | Oct 1, 1996 | Substantially Equivalent |
| K953804 | VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS | Sep 26, 1995 | Substantially Equivalent |