Product code HQB
- Device name
- Photocoagulator And Accessories
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4690
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | Vortex Surgical, Inc. | 2022-11-03 |
| 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 |
| K954306 | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 |
| K954307 | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 |
| K954308 | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR 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 |
| K922735 | ZIESS ENDOPROBE | Carl Zeiss, Inc. | 1992-07-09 |
| K882679 | SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | 1988-12-14 |
| K882441 | SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | 1988-09-26 |
| K881926 | REUSABLE FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-06-06 |
| K860011 | NIDEK AC-2000 LASER SYSTEM | Nidek, Inc. | 1986-02-07 |
| K844356 | SYSTEM 930 ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1985-05-16 |
| K844209 | ARGON/KRYPTON LASER SYSTEM 8500 | Cooper Lasersonics, Inc. | 1985-02-06 |
| K844197 | ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS | Nidek, Inc. | 1984-12-24 |
| K844198 | ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE | Nidek, Inc. | 1984-12-24 |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | American Medical Optics | 1984-11-08 |
| K801877 | SLIT LAMP ATTACHMENT | Cavitron Corp. | 1980-09-16 |
| K780345 | PHOTOCOAGULATOR LASER | Cavitron Corp. | 1978-05-09 |
| K772213 | LAMP DELIVERY SYS.-PHOTOCOAGULATION | Varian Assoc., Inc. | 1977-12-13 |
| K760444 | PHOTOCOAGULATOR, LOG 3 PORTABLE XENON | Varian Assoc., Inc. | 1976-08-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10817489027766 | 25ga Stiff Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connec | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027704 | 25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027698 | 23ga Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027681 | 27ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027674 | 25ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027711 | 27ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027728 | 23ga Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027735 | 25ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027742 | 27ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027759 | 23ga Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connector | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027773 | 27ga Stiff Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connec | KATALYST SURGICAL LLC | 2019-04-03 |
| 10817489027483 | Laser Probe OS4, MultiFlex, 23ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489027551 | Laser Probe OS4, MultiFlex Inverted Extendable, 25ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489027544 | Laser Probe OS4, MultiFlex Inverted Extendable, 23ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489027520 | Laser Probe OS4, MultiFlex Extendable, 23ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489027513 | Laser Probe OS4, MultiFlex Inverted, 25ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489027506 | Laser Probe OS4, MultiFlex Inverted, 23ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489027490 | Laser Probe OS4, MultiFlex, 25ga | KATALYST SURGICAL LLC | 2019-03-19 |
| 10817489024925 | 23ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector | KATALYST SURGICAL LLC | 2017-03-24 |
| 10817489024710 | 23ga Flex Tapered Illum Laser Probe, Iridex Connector/Short 19ga; Box of 10 | KATALYST SURGICAL LLC | 2017-03-24 |
| 10817489023867 | 25ga Flex Tapered Illum Laser Probe, Iridex Connector/Short 19ga; Box of 10 | KATALYST SURGICAL LLC | 2017-03-22 |
| 00817489024621 | 25ga Steerable Revolver | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024614 | 23ga Steerable Revolver | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024607 | Revolver Handle, 27ga Tapered Curved | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024591 | Revolver Handle, 25ga Tapered Curved | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024584 | Revolver Handle, 23ga Tapered Curved | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024577 | Revolver Handle, 27ga Straight | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024560 | Revolver Handle, 25ga Straight | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024553 | Revolver Handle, 23ga Straight | KATALYST SURGICAL LLC | 2016-09-24 |
| 00817489024546 | Revolver Handle, 20ga Straight | KATALYST SURGICAL LLC | 2016-09-24 |