HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
FDA 510(k) clearance K170520 · decided 2017-03-22
Clearance details
- K-number
- K170520
- Device name
- HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
- Applicant
- Alcon Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-22
- Decision date
- 2017-03-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MLZ
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vista Ophthalmics Vitrectomy Probe (K220030) | Vista Ophthalmics, LLC | 2022-05-04 |
| ENHANCED ULTRA VIT PROBE (K093305) | Alcon Research, Ltd. | 2010-04-02 |
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
Recalls involving this device
No recalls on record reference this clearance.
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| AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113) | Alcon Research, Ltd. | 2025-02-14 |