FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCS 100 (OCULAR COMPARATOR SYSTEM)
K Number: K874220
·
Decision Dec 23, 1987
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
50
Review Days
68
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Basic Information
- Device Name
- OCS 100 (OCULAR COMPARATOR SYSTEM)
- K Number
- K874220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ocular Instruments, Inc.
- Date Received
- October 16, 1987
- Decision Date
- December 23, 1987
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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| 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 |