ClearanceBrief
Panels › Ophthalmic › Product code HQF · Class 2

Laser, Ophthalmic

Regulation 886.4390

2510(k)s in 12 months (180 all time)
1recalls in 12 months (32 all time)
21recalls that name a 510(k)
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Top companies in HQF

DateFirm and productCodeLinked 510(k)
Dec 31, 2025Beaver-Visitec International, Inc.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Open, Classified
HQFK240615
Jun 27, 2023Ellex Medical Pty Ltd.
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Open, Classified
HQFK081565
K142398
Apr 14, 2021Dutch Ophthalmic USA, Inc.
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Open, Classified
HQFK031023
Jul 15, 2016Topcon Medical Laser Systems, Inc
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Terminated
HQFK123542
Feb 1, 2016Laserex Systems Inc.
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to
Terminated
HQFK052777
Feb 19, 2015Nidek Inc
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy
Terminated
HQFK110228
Jan 15, 2015Ziemer Usa Inc
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Terminated
HQFK131207
Dec 23, 2014Bausch & Lomb Inc
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used f
Terminated
HQFK133486
Dec 23, 2014Bausch & Lomb Inc
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for
Terminated
HQFK133486
Dec 23, 2014Bausch & Lomb Inc
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Terminated
HQFK133486
Nov 17, 2014Nidek Inc
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation fo
Terminated
HQFK110228
Nov 17, 2014Nidek Inc
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Terminated
HQFK110228
Sep 30, 2014Lumenis, Inc.
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink"
Terminated
HQFK130195
Jul 30, 2014Nidek Inc
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Terminated
HQFK110228
Mar 7, 2014Carl Zeiss Meditec AG
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corne
Terminated
HQFK100253
Jan 23, 2014Ziemer Usa Inc
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring
Terminated
HQFK112154
Jul 19, 2013Topcon Medical Laser Systems, Inc
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Terminated
HQFK100019
Apr 12, 2011Ellex Medical Pty Ltd
Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
Terminated
HQFNone listed
Apr 12, 2011Ellex Medical Pty Ltd
Ellex Tango LT5106-T ophthalmic laser (not sold in USA)
Terminated
HQFNone listed
Apr 12, 2011Ellex Medical Pty Ltd
Alcon 3000LE ophthalmic laser
Terminated
HQFNone listed
Apr 12, 2011Ellex Medical Pty Ltd
Ellex Ultra Q LQP3106-U ophthalmic laser
Terminated
HQFNone listed
Apr 12, 2011Ellex Medical Pty Ltd
Ellex Super Q LQP3106 ophthalmic laser
Terminated
HQFNone listed
Sep 30, 2010Lumenis, Inc.
Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
Terminated
HQFNone listed
Sep 11, 2010Peregrine Surgical Ltd
Peregrine 20 GA Endo Ocular Adjustable Laser Probe
Terminated
HQFNone listed
May 28, 2010Bausch & Lomb Inc
Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model CX5310, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench c
Terminated
HQFK033941
Jan 20, 2010Ellex Medical Pty Ltd
Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.
Terminated
HQFNone listed
Jan 20, 2010Ellex Medical Pty Ltd
Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
Terminated
HQFNone listed
Nov 6, 2008Alcon Laboratories, Inc.
PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and pos
Terminated
HQFNone listed
Dec 20, 2007Ellex USA
Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in
Terminated
HQFK052777
Dec 20, 2007Ellex USA
Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
Terminated
HQFK041598
Jul 20, 2004Alcon Research, Ltd.
Opthalmic Laser, product number 8065-5000-1
Terminated
HQFNone listed
Dec 17, 2003LightMed USA Inc
Model LightLas 532 Opthalmic Photocoagulator Laser
Terminated
HQFK010372
K990075

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