FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I/A - VFE SYSTEM II
K Number: K854868
·
Decision Feb 7, 1986
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
21
Review Days
65
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Basic Information
- Device Name
- I/A - VFE SYSTEM II
- K Number
- K854868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Mira, Inc.
- Date Received
- December 4, 1985
- Decision Date
- February 7, 1986
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K941495 | RETURN PATH DIATHERMY HANDLE | Jul 15, 1994 | Substantially Equivalent |
| K933527 | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | Jan 25, 1994 | Substantially Equivalent |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Oct 19, 1992 | Substantially Equivalent |
| K894248 | CONVERTER SYSTEM | Feb 27, 1990 | Substantially Equivalent |
| K891601 | POWER OPERATED AND CONTROLLED VITREOUS SCISSORS | May 23, 1989 | Substantially Equivalent |
| K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC | May 8, 1989 | Substantially Equivalent |
| K863246 | MIRALITE | Oct 31, 1986 | Substantially Equivalent |
| K863591 | ENDOPHOTOCOAGULATION PROBE | Oct 10, 1986 | Substantially Equivalent |