510(k) K093305
- Device
- ENHANCED ULTRA VIT PROBE
- Applicant
- ALCON RESEARCH, LTD.
- 510(k) number
- K093305
- Product code
- MLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-04-02
- Date received
- 2009-10-22
- Regulation
- 886.4150
- Classification name
- Vitrectomy, Instrument Cutter
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN A KAUFMAN
- Address
- 15800 Alton Pkwy. Irvine CA US 92618 92618
FDA Registration Numbers#
- 3015456951
- 3023125126
- 3003398873
- 2935428
- 1649518
- 3033485955
- 9681572
- 1928237
- 3008692839
- 3012236936
- 1644019
- 2523835
- 3010047402
- 2028159
- 1319660
- 1650907
- 3005941719
- 3010208880
- 3012123033
- 3029973819
- 3010291427
- 2953359
- 3005012805
- 2126666
Source Documents#
Other 510(k) Records For Product Code MLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | 2022-05-04 |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Alcon Research, Ltd. | 2017-03-22 |
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Advanced Medical Optics, Inc. | 2008-10-08 |
Legacy Summary#
summary
FDA Review#
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