Vitreq disposable laser probes, light fibers and Chandelier
FDA 510(k) clearance K182646 · decided 2019-05-01
Clearance details
- K-number
- K182646
- Device name
- Vitreq disposable laser probes, light fibers and Chandelier
- Applicant
- VitreQ BV
- Decision
- Substantially Equivalent
- Date received
- 2018-09-24
- Decision date
- 2019-05-01
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- HQB
- Device class
- 2
- Regulation number
- 886.4690
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Vierpolders, NL
- 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 |
|---|
| Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers (K220263) | Vortex Surgical, Inc. | 2022-11-03 |
| MAXReach Laser Probe (K191846) | Vortex Surgical, Inc. | 2019-12-23 |
| PEREGRINE CURVED ILLUMINATING LASER PROBE (K132614) | Peregrine Surgical , Ltd. | 2013-11-14 |
| 23GA CURVED ILLUMINATING LASER PROBE (K122997) | Peregrine Surgical , Ltd. | 2013-06-26 |
| PEREGRINE 23GA CURVED LASER PROBE (K122905) | Peregrine Surgical , Ltd. | 2013-04-30 |
| SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (K113857) | Synergetics, Inc. | 2012-04-23 |
| 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951) | Alcon Research, Ltd. | 2011-10-17 |
| NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (K111493) | Nidek Co., Ltd. | 2011-07-27 |
| NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228) | Nidek Incorporated | 2011-02-23 |
| LC-250 INFRARED LIGHT COAGULATOR (K964380) | Nk-Optik America | 1997-01-22 |
| GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (K954306) | Gamp & Assoc. | 1995-12-22 |
| GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (K954308) | Gamp & Assoc. | 1995-12-22 |
Recalls involving this device
No recalls on record reference this clearance.