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.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| 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 |
Top Applicants
- Gamp & Assoc. — 3 clearances
- Nidek, Inc. — 3 clearances
- Peregrine Surgical , Ltd. — 3 clearances
- Cavitron Corp. — 2 clearances
- Surgical Laser Technologies, Inc. — 2 clearances
