FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS)
K Number: K974599
·
Decision Mar 2, 1998
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
6
Review Days
83
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Basic Information
- Device Name
- ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS)
- K Number
- K974599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Opti-Centre Laboratories
- Date Received
- December 9, 1997
- Decision Date
- March 2, 1998
- 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 Opti-Centre Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K043129 | PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) | Jan 12, 2005 | Substantially Equivalent |
| K010256 | ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL | Mar 26, 2001 | Substantially Equivalent |
| K001227 | ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT | Jun 29, 2000 | Substantially Equivalent |
| K992589 | RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY | Aug 26, 1999 | Substantially Equivalent |
| K983496 | RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T | Mar 29, 1999 | Substantially Equivalent |