FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENHANCED ULTRA VIT PROBE
K Number: K093305
·
Decision Apr 2, 2010
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
3
Applicant Total
16
Review Days
162
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Basic Information
- Device Name
- ENHANCED ULTRA VIT PROBE
- K Number
- K093305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Research, Ltd.
- Date Received
- October 22, 2009
- Decision Date
- April 2, 2010
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MLZ), ordered by most recent decision date.
Vista Ophthalmics Vitrectomy Probe
FDA 510(k)
FDA Class 2
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HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
FDA 510(k)
FDA Class 2
·Ophthalmic
VITRECTOMY CUTTER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Alcon Research, Ltd.
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|---|---|---|---|
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| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Mar 22, 2017 | Substantially Equivalent |
| K141065 | CONSTELLATION VISION SYSTEM | Aug 22, 2014 | Substantially Equivalent |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | Jun 21, 2012 | Substantially Equivalent |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) | Mar 27, 2012 | Substantially Equivalent |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | Oct 17, 2011 | Substantially Equivalent |
| K110166 | CLEARCUT S SAFETY KNIFE | May 20, 2011 | Substantially Equivalent |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | May 10, 2011 | Substantially Equivalent |
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | Oct 21, 2010 | Substantially Equivalent |
| K091777 | ALCON ULTRACHOPPER | Oct 20, 2009 | Substantially Equivalent |