FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LANDERS VITRECTOMY LENS RING SYSTEMS
K Number: K850991
·
Decision Mar 29, 1985
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
6
Applicant Total
50
Review Days
18
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Basic Information
- Device Name
- LANDERS VITRECTOMY LENS RING SYSTEMS
- K Number
- K850991
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ocular Instruments, Inc.
- Date Received
- March 11, 1985
- Decision Date
- March 29, 1985
- Product Code
- HNH
- 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 |
|---|---|---|---|
| HNH | Ring, Ophthalmic (Flieringa) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNH), ordered by most recent decision date.
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LANDERS THREE STRUT VITRECTOMY LENS RING
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LANDERS VITRECTOMY LENS RING W/INFUSION
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RK VACUUM FIXATION RING SYSTEM
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GELENDER VACUUM FIXATION RING SYS
FDA 510(k)
FDA Class 1
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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 |
| 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 |
| 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 |