ENHANCED ULTRA VIT PROBE
FDA 510(k) clearance K093305 · decided 2010-04-02
Clearance details
- K-number
- K093305
- Device name
- ENHANCED ULTRA VIT PROBE
- Applicant
- Alcon Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-22
- Decision date
- 2010-04-02
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- MLZ
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alcon Research
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117) | Alcon Research, Ltd. | 2025-12-12 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S069) | Alcon Research, Ltd. | 2025-10-03 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116) | Alcon Research, Ltd. | 2025-09-18 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115) | Alcon Research, Ltd. | 2025-08-25 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S068) | Alcon Research, Ltd. | 2025-07-25 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111) | Alcon Research, Ltd. | 2025-06-18 |
| PROVSIC Ophthalmic Viscosurgical Device (P890047/S067) | Alcon Research, Ltd. | 2025-02-26 |
| AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113) | Alcon Research, Ltd. | 2025-02-14 |