HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
FDA 510(k) K170520 · Alcon Research, Ltd.
510(k) numberK170520
Submission
- Device name
- HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
- Applicant
- Alcon Research, Ltd.
Lake Forest, CA, US - Received
- February 22, 2017
- Decision date
- March 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLZ – Vitrectomy, Instrument Cutter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
Other 510(k)s with product code MLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy ProbeMLZ · Traditional | Vista Ophthalmics, LLC | 05/04/2022SE |
| K093305 | Enhanced Ultra Vit ProbeMLZ · Traditional | Alcon Research, Ltd. | 04/02/2010SE |
| K081681 | Vitrectomy Cutter and AccessoriesMLZ · Abbreviated | Advanced Medical Optics, Inc. | 10/08/2008SE |
More from Advanced Medical Optics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191650 | LEGION SystemHQC · Traditional | 11/01/2019SE |
| K161794 | CENTURION Vision System (Active SentryTM)HQC · Traditional | 04/14/2017SE |
| K141065 | Constellation Vision SystemHQE · Traditional | 08/22/2014SE |
| K121031 | Wavelight FS200 Patient Interface 1505GEX · Abbreviated | 06/21/2012SE |
| K112977 | Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)MSS · Abbreviated | 03/27/2012SE |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…HQB · Traditional | 10/17/2011SE |
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | 05/20/2011SE |
| K102860 | Alcon Multi-Pirpose Disinfecting SolutionLPN · Traditional | 05/10/2011SE |
| K101006 | Wavelight FS200 Laser System Model: FS200GEX · Traditional | 10/21/2010SE |
| K093305 | Enhanced Ultra Vit ProbeMLZ · Traditional | 04/02/2010SE |
Questions and answers
When was HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ cleared by the FDA?
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) received a 510(k) decision of Substantially Equivalent on March 22, 2017, 28 days after the submission was received.
What is the product code of K170520?
The FDA product code is MLZ – Vitrectomy, Instrument Cutter, a Class II (moderate risk) device regulated under 21 CFR 886.4150.