FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
K Number: K935302
·
Decision Apr 1, 1994
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
9
Applicant Total
50
Review Days
150
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Basic Information
- Device Name
- OSHER SURGICAL GONIO/POSTERIOR POLE LENS
- K Number
- K935302
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1660
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ocular Instruments, Inc.
- Date Received
- November 2, 1993
- Decision Date
- April 1, 1994
- Product Code
- HKS
- 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 |
|---|---|---|---|
| HKS | Prism, Gonioscopic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKS), ordered by most recent decision date.
FAMILY OF DISPOSABLE LENSES
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MCINTYRE SURGICAL GONIOLENS
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KARICKHOFF DIAGNOSTIC/LASER LENS
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ABRAHAM IRIDECTOMY LENS (YAG LASER)
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RITCH TRABECULOPLASTY LASER LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Ocular Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Mar 4, 2002 | Substantially Equivalent |
| K012096 | DISPOSABLE VITRECTOMY LENS | Aug 24, 2001 | 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 |
| 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 |