Product Code: HQB FDA class 2 21 CFR 886.4690

Photocoagulator And Accessories

Ophthalmic

A Photocoagulator and Accessories is an ophthalmic surgical device that uses focused light energy, typically from a xenon arc or argon laser source, to thermally coagulate retinal tissue for the treatment of retinal tears, diabetic retinopathy, macular degeneration, and other vascular retinal conditions. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQB and is regulated under 21 CFR 886.4690, within the Ophthalmic medical specialty. It is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HQB
Device Class: FDA class 2
Regulation Number: 886.4690
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220263	Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers	Nov 03, 2022	Substantially Equivalent	Vortex Surgical, Inc.
K191846	MAXReach Laser Probe	Dec 23, 2019	Substantially Equivalent	Vortex Surgical, Inc.
K182646	Vitreq disposable laser probes, light fibers and Chandelier	May 01, 2019	Substantially Equivalent	VitreQ BV
K132614	PEREGRINE CURVED ILLUMINATING LASER PROBE	Nov 14, 2013	Substantially Equivalent	Peregrine Surgical , Ltd.
K122997	23GA CURVED ILLUMINATING LASER PROBE	Jun 26, 2013	Substantially Equivalent	Peregrine Surgical , Ltd.
K122905	PEREGRINE 23GA CURVED LASER PROBE	Apr 30, 2013	Substantially Equivalent	Peregrine Surgical , Ltd.
K113857	SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE	Apr 23, 2012	Substantially Equivalent	Synergetics, Inc.
K110951	27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA	Oct 17, 2011	Substantially Equivalent	Alcon Research, Ltd.
K111493	NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI	Jul 27, 2011	Substantially Equivalent	Nidek Co., Ltd.
K110228	NIDEK MULTICOLOR LASER PHOTOCOAGULATOR	Feb 23, 2011	Substantially Equivalent	Nidek Incorporated
K964380	LC-250 INFRARED LIGHT COAGULATOR	Jan 22, 1997	Substantially Equivalent	Nk-Optik America
K954308	GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE	Dec 22, 1995	Substantially Equivalent	Gamp & Assoc.
K954307	GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE	Dec 22, 1995	Substantially Equivalent	Gamp & Assoc.
K954306	GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE	Dec 22, 1995	Substantially Equivalent	Gamp & Assoc.
K923531	OPTOSCALPEL I LASER SYSTEM	Nov 12, 1993	Substantially Equivalent	Optomed Corp.
K924090	THE ENDO OPTIKS MICROPROBE	Feb 01, 1993	Substantially Equivalent	Endo Optics, Inc.
K922735	ZIESS ENDOPROBE	Jul 09, 1992	Substantially Equivalent	Carl Zeiss, Inc.
K882679	SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION	Dec 14, 1988	Substantially Equivalent	Surgical Laser Technologies, Inc.
K882441	SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION	Sep 26, 1988	Substantially Equivalent	Surgical Laser Technologies, Inc.
K881926	REUSABLE FIBEROPTIC LIGHTPIPE	Jun 06, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K860011	NIDEK AC-2000 LASER SYSTEM	Feb 07, 1986	Substantially Equivalent	Nidek, Inc.
K844356	SYSTEM 930 ARGON PHOTOCOAGULATOR	May 16, 1985	Substantially Equivalent	Coherent Medical Group
K844209	ARGON/KRYPTON LASER SYSTEM 8500	Feb 06, 1985	Substantially Equivalent	Cooper Lasersonics, Inc.
K844198	ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE	Dec 24, 1984	Substantially Equivalent	Nidek, Inc.
K844197	ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS	Dec 24, 1984	Substantially Equivalent	Nidek, Inc.
K843966	ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS	Nov 08, 1984	Substantially Equivalent	American Medical Optics
K801877	SLIT LAMP ATTACHMENT	Sep 16, 1980	Substantially Equivalent	Cavitron Corp.
K780345	PHOTOCOAGULATOR LASER	May 09, 1978	Substantially Equivalent	Cavitron Corp.
K772213	LAMP DELIVERY SYS.-PHOTOCOAGULATION	Dec 13, 1977	Substantially Equivalent	Varian Assoc., Inc.
K760444	PHOTOCOAGULATOR, LOG 3 PORTABLE XENON	Aug 26, 1976	Substantially Equivalent	Varian Assoc., Inc.