HQB · Photocoagulator And Accessories
Ophthalmic · 21 CFR 886.4690 · Class 2
Overview
| Product Code | HQB |
|---|---|
| Device Name | Photocoagulator And Accessories |
| Regulation | 21 CFR 886.4690 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.
Classification Rationale
Class II.
Cleared Devices (30)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | Vortex Surgical, Inc. | Nov 3, 2022 | SESE |
| K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | Dec 23, 2019 | SESE |
| K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | May 1, 2019 | SESE |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | Nov 14, 2013 | SESE |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | Peregrine Surgical , Ltd. | Jun 26, 2013 | SESE |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | Peregrine Surgical , Ltd. | Apr 30, 2013 | SESE |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Synergetics, Inc. | Apr 23, 2012 | SESE |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | Alcon Research, Ltd. | Oct 17, 2011 | SESE |
| K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | Nidek Co., Ltd. | Jul 27, 2011 | SESE |
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR | Nidek Incorporated | Feb 23, 2011 | SESE |
| K964380 | LC-250 INFRARED LIGHT COAGULATOR | Nk-Optik America | Jan 22, 1997 | SESE |
| K954308 | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | Gamp & Assoc. | Dec 22, 1995 | SESE |
| K954307 | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | Gamp & Assoc. | Dec 22, 1995 | SESE |
| K954306 | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | Gamp & Assoc. | Dec 22, 1995 | SESE |
| K923531 | OPTOSCALPEL I LASER SYSTEM | Optomed Corp. | Nov 12, 1993 | SESE |
| K924090 | THE ENDO OPTIKS MICROPROBE | Endo Optics, Inc. | Feb 1, 1993 | SESE |
| K922735 | ZIESS ENDOPROBE | Carl Zeiss, Inc. | Jul 9, 1992 | SESE |
| K882679 | SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | Dec 14, 1988 | SESE |
| K882441 | SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION | Surgical Laser Technologies, Inc. | Sep 26, 1988 | SESE |
| K881926 | REUSABLE FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | Jun 6, 1988 | SESE |
| K860011 | NIDEK AC-2000 LASER SYSTEM | Nidek, Inc. | Feb 7, 1986 | SESE |
| K844356 | SYSTEM 930 ARGON PHOTOCOAGULATOR | Coherent Medical Group | May 16, 1985 | SESE |
| K844209 | ARGON/KRYPTON LASER SYSTEM 8500 | Cooper Lasersonics, Inc. | Feb 6, 1985 | SESE |
| K844198 | ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE | Nidek, Inc. | Dec 24, 1984 | SESE |
| K844197 | ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS | Nidek, Inc. | Dec 24, 1984 | SESE |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | American Medical Optics | Nov 8, 1984 | SESE |
| K801877 | SLIT LAMP ATTACHMENT | Cavitron Corp. | Sep 16, 1980 | SESE |
| K780345 | PHOTOCOAGULATOR LASER | Cavitron Corp. | May 9, 1978 | SESE |
| K772213 | LAMP DELIVERY SYS.-PHOTOCOAGULATION | Varian Assoc., Inc. | Dec 13, 1977 | SESE |
| K760444 | PHOTOCOAGULATOR, LOG 3 PORTABLE XENON | Varian Assoc., Inc. | Aug 26, 1976 | SESE |
Top Applicants
- Peregrine Surgical , Ltd. — 3 clearances
- Nidek, Inc. — 3 clearances
- Gamp & Assoc. — 3 clearances
- Vortex Surgical, Inc. — 2 clearances
- Varian Assoc., Inc. — 2 clearances
