FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITRECTOMY CUTTER AND ACCESSORIES
K Number: K081681
·
Decision Oct 8, 2008
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
3
Applicant Total
8
Review Days
113
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Basic Information
- Device Name
- VITRECTOMY CUTTER AND ACCESSORIES
- K Number
- K081681
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Medical Optics, Inc.
- Date Received
- June 17, 2008
- Decision Date
- October 8, 2008
- Product Code
- MLZ
- 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 |
|---|---|---|---|
| MLZ | Vitrectomy, Instrument Cutter | FDA class 2 | Ophthalmic |
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ENHANCED ULTRA VIT PROBE
FDA 510(k)
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Other Clearances by Advanced Medical Optics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | Oct 2, 2008 | Substantially Equivalent |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | Apr 7, 2006 | Substantially Equivalent |
| K042562 | LENS PLUS REWETTING DROPS | Jul 29, 2005 | Substantially Equivalent |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | Apr 5, 2005 | Substantially Equivalent |
| K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | Oct 19, 2004 | Substantially Equivalent |
| K032030 | BLINK CL LUBRICANT EYE DROPS | Sep 25, 2003 | Substantially Equivalent |
| K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Apr 4, 2003 | Substantially Equivalent |