FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE VITRECTOMY LENS
K Number: K012096
·
Decision Aug 24, 2001
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
40
Applicant Total
50
Review Days
50
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Basic Information
- Device Name
- DISPOSABLE VITRECTOMY LENS
- K Number
- K012096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ocular Instruments, Inc.
- Date Received
- July 5, 2001
- Decision Date
- August 24, 2001
- Product Code
- HJK
- 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 |
|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | FDA class 2 | Ophthalmic |
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Other Clearances by Ocular Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Mar 4, 2002 | Substantially Equivalent |
| K933976 | MANDELKORN SUTURE LYSIS LENS | Nov 8, 1994 | Substantially Equivalent |
| K933264 | RITCH NYLON SUTURE LASER LENS | Oct 31, 1994 | Substantially Equivalent |
| K941420 | 50 DEGREE HRI PRISM LENS | Aug 29, 1994 | Substantially Equivalent |
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | Apr 1, 1994 | Substantially Equivalent |
| K921414 | TROKEL /3 GONIO LASER LENS | Nov 16, 1992 | Substantially Equivalent |
| K923670 | BYRNE EXPULSIVE LENS | Nov 16, 1992 | Substantially Equivalent |
| K914051 | PEDIATRIC VITRECTOMY LENS SET | Dec 9, 1991 | Substantially Equivalent |
| K914117 | LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET | Nov 13, 1991 | Substantially Equivalent |
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Aug 21, 1991 | Substantially Equivalent |