Photocoagulator And Accessories

Product Code: HQB

Ophthalmic Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 886.4690


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as HQB

4291Photocoagulator And AccessoriesOphthalmic Photocoagulator.

Total Product Life Cycle (TPLC) Devices

4291Photocoagulator And AccessoriesOphthalmic Photocoagulator.

FDA Consensus Standards

Photocoagulator And Accessories [32410]21 CFR §886.4690 🔎
Photocoagulator And Accessories [29877]21 CFR §886.4690 🔎
Photocoagulator And Accessories [29297]21 CFR §886.4690 🔎

Pre-market Notifications for HQB

K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical Inc
K191846MAXReach Laser ProbeVortex Surgical Inc.
K182646Vitreq Disposable Laser Probes, Light Fibers And ChandelierVitreq B.V.
K132614PEREGRINE CURVED ILLUMINATING LASER PROBEPEREGRINE SURGICAL, LTD.
K12299723GA CURVED ILLUMINATING LASER PROBEPEREGRINE SURGICAL LTD.
K122905PEREGRINE 23GA CURVED LASER PROBEPEREGRINE SURGICAL, LTD.
K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBESYNERGETICS, INC
K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXINIDEK CO., LTD.
K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAALCON RESEARCH, LTD.
K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORNIDEK INCORPORATED
K964380LC-250 INFRARED LIGHT COAGULATORNK-OPTIK AMERICA
K954308GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBEGAMP & ASSOC.
K954307GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBEGAMP & ASSOC.
K954306GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBEGAMP & ASSOC.
K924090THE ENDO OPTIKS MICROPROBEENDO OPTICS, INC.

Global Unique Device Identification Database

10380657515933Photocoagulator and accessories
10380657515902Photocoagulator and accessories
10380657511140Photocoagulator and accessories
10380657511133Photocoagulator and accessories
10380657511126Photocoagulator and accessories
10380657511119Photocoagulator and accessories
10380657509895Photocoagulator and accessories
10380657509857Photocoagulator and accessories
00380657509836Photocoagulator and accessories
10380657509819Photocoagulator and accessories
10380657509796Photocoagulator and accessories
10380657509789Photocoagulator and accessories
10380657508034Photocoagulator and accessories
10380650104035Photocoagulator and accessories
10632307002196Photocoagulator And Accessories

Maude Adverse Events

2020-03-23
2020-03-23
25GA ILLUMINATED DIRECTIONAL LASER PROBEBAUSCH + LOMB2020-03-19
23GA ILLUMINATED DIRECTIONAL LASER PROBEBAUSCH + LOMB2020-03-19
25GA ILLUMINATED DIRECTIONAL II LASER PROBEBAUSCH + LOMB2020-03-17
23GA ILLUMINATED DIRECTIONAL II LASER PROBEBAUSCH + LOMB2020-03-17
ALCON, ENGAUGEALCON LABORATORIES, INC.2020-02-11
25GA ILLUMINATED DIRECTIONAL LASER PROBEBAUSCH + LOMB2018-08-22
25GA ILLUMINATED DIRECTIONAL LASER PROBEBAUSCH + LOMB2018-08-22
25GA/0.5 MM STEPPED ILLUMINATING LASER PROBEPEREGRINE SURGICAL, LTD.2018-01-19
SYNERGETICS ENDO-OCULAR LASER PROBEBAUSCH + LOMB2017-05-31
DIRECTIONAL LASER PROBESYNERGETICS USA, INC.2017-05-08
MONTERIS MEDICALMONTERIS MEDICAL2016-08-30
DIRECTIONAL LASER PROBESYNERGETICS, INC.2014-09-12
ALCON SHIELDED BULLET ILLUMINATORALCON SURGICAL2013-03-27
ALCONALCON SURGICAL2013-02-18
ONE STEP CANNULASYNERGETICS2012-03-08
23 GAUGE ONE STEP VALVED CANNULASYNERGETICS2012-03-02
SYNERGETICS 23 G DIRECTIONAL LASER PROBESYNERGETICS2012-02-26
ALCON TOTAL PLUS 25+ VITRECTOMY PACKALCON LABORATORIES2011-11-04
ONE-STEP CANNULASYNERGETICS2011-07-20
SYNERGETICS DIRECTIONAL LASER PROBESYNERGETICS2011-03-31
NOVUS VERDILUMENIS, INC.2006-10-06
NOVUS 2000COHERNT MEDICAL2005-06-22
EYELIT LASERALCON - IRVING TECHNOLOGY CENTER2005-06-03
EYELIT LASERALCON - IRVINE TECHNOLOGY CENTER2005-06-03
NOVUS 2000LUMENIS, INC. (FORMERLY COHERENT)2005-04-05
EYELITE LASERALCON - IRVINE TECHNOLOGY CENTER2005-03-02
OPHTHALAS 532 EYELITEALCON - IRVINE TECHNOLOGY CTR2004-12-09
OPHTHALAS 532 EYELITEALCON - IRVINE TECHNOLOGY CENTER2004-08-13
OPHTHALAS 532 EYELITEALCON-IRVINE TECHNOLOGY CENTER2003-12-24
ELITE E85LUMENIS, INC.2003-12-18
OPHTHALAS 532 EYELITEALCON-IRVINE TECHNOLOGY CENTER2003-11-20
OPHTHALAS 532 EYELITEALCON- IRVINE TECHNOLOGY CENTER2001-11-16
OPHTHALAS SPALCON-IRVINE TECHNOLOGY CENTER2000-08-18
930OPHTHALMIC ARGON PHOTOCOAGULATORCOHERENT MEDICAL LASER GROUP1997-02-13
OPHTHALAS 532 LASERALCON LABORATORIES, INC.1996-10-04
LASERHGM, INC.1994-06-13
ARGON BEAM COAGULAR - PROBEBIRTCHER MEDICAL SYSTEMS1992-12-29
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