510(k) K220263
- Device
- Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- Applicant
- Vortex Surgical Inc
- 510(k) number
- K220263
- Product code
- HQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-03
- Date received
- 2022-01-31
- Regulation
- 886.4690
- Classification name
- Photocoagulator And Accessories
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andrew Ritts
- Address
- 680 Crown Industrial Ct. Suite F Chesterfield MO US 63005 63005
FDA Registration Numbers#
- 3015456951
- 8030392
- 3010487482
- 9681121
- 3012037425
- 1932402
- 1928237
- 2523835
- 3007589150
- 3002808022
- 2936921
- 9611516
- 2028159
- 1018470
- 9615745
- 3016678045
- 3002807715
- 1650907
- 2246552
- 3004467263
- 3004497289
- 3010208880
- 2529392
- 1313525
- 3002991496
- 3010220595
- 3013002167
Source Documents#
Other 510(k) Records For Product Code HQB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019-12-23 |
| K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019-05-01 |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | 2013-11-14 |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | 2013-06-26 |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | Peregrine Surgical , Ltd. | 2013-04-30 |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Synergetics, Inc. | 2012-04-23 |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | Alcon Research, Ltd. | 2011-10-17 |
| K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | Nidek Co., Ltd. | 2011-07-27 |
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR | Nidek Incorporated | 2011-02-23 |
| K964380 | LC-250 INFRARED LIGHT COAGULATOR | Nk-Optik America | 1997-01-22 |
| K954308 | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 |
| K954307 | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 |
| K954306 | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 |
| K923531 | OPTOSCALPEL I LASER SYSTEM | Optomed Corp. | 1993-11-12 |
| K924090 | THE ENDO OPTIKS MICROPROBE | Endo Optics, Inc. | 1993-02-01 |
Legacy Summary#
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FDA Review#
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