FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OMS QUARTZ INFUSION CONTACT LENS
K Number: K820223
·
Decision Feb 5, 1982
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
7
Applicant Total
21
Review Days
9
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Basic Information
- Device Name
- OMS QUARTZ INFUSION CONTACT LENS
- K Number
- K820223
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1395
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Optical Micro Systems, Inc.
- Date Received
- January 27, 1982
- Decision Date
- February 5, 1982
- Product Code
- HJI
- 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 |
|---|---|---|---|
| HJI | Lens, Fundus, Hruby, Diagnostic | FDA class 1 | Ophthalmic |
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Other Clearances by Optical Micro Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950218 | OMS SLIMLINE PHACO HANDPIECE | Jul 17, 1995 | Substantially Equivalent |
| K946054 | DIPLOMAX | Jul 11, 1995 | Substantially Equivalent |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | Mar 14, 1994 | Substantially Equivalent |
| K935226 | I/V POLE | Feb 16, 1994 | Substantially Equivalent |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | Jan 25, 1994 | Substantially Equivalent |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | Feb 12, 1987 | Substantially Equivalent |
| K844373 | O.M.S. ULTRA-PHACO | Dec 19, 1985 | Substantially Equivalent |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | Aug 21, 1985 | Substantially Equivalent |
| K844895 | OMS SILICONE OIL INJECTOR | Jun 24, 1985 | Substantially Equivalent |
| K844467 | OMS CRYO | Feb 22, 1985 | Substantially Equivalent |