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)
Top companies in HQF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2025 | Beaver-Visitec International, Inc. BVI Leos Laser and Endoscopy System. Model Number: OME6000U. Open, Classified |
HQF | K240615 |
| Jun 27, 2023 | Ellex 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 |
HQF | K081565 K142398 |
| Apr 14, 2021 | Dutch Ophthalmic USA, Inc. Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system
Product Code: 7510.ALC Open, Classified |
HQF | K031023 |
| Jul 15, 2016 | Topcon 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 |
HQF | K123542 |
| Feb 1, 2016 | Laserex 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 |
HQF | K052777 |
| Feb 19, 2015 | Nidek 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 |
HQF | K110228 |
| Jan 15, 2015 | Ziemer Usa Inc Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries. Terminated |
HQF | K131207 |
| Dec 23, 2014 | Bausch & 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 |
HQF | K133486 |
| Dec 23, 2014 | Bausch & 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 |
HQF | K133486 |
| Dec 23, 2014 | Bausch & Lomb Inc Bausch & Lomb Stellaris PC w/ Laser, BL14304
The responsible firm name is Bausch & Lomb Incorporated Rochester, NY Terminated |
HQF | K133486 |
| Nov 17, 2014 | Nidek 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 |
HQF | K110228 |
| Nov 17, 2014 | Nidek Inc MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. Terminated |
HQF | K110228 |
| Sep 30, 2014 | Lumenis, 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 |
HQF | K130195 |
| Jul 30, 2014 | Nidek Inc MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. Terminated |
HQF | K110228 |
| Mar 7, 2014 | Carl 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 |
HQF | K100253 |
| Jan 23, 2014 | Ziemer 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 |
HQF | K112154 |
| Jul 19, 2013 | Topcon Medical Laser Systems, Inc PASCAL and PASCAL Streamline (532 nm.577 nm);
Treats the patient's eye. Terminated |
HQF | K100019 |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Solo LT5106-S ophthalmic laser (not sold in USA) Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Tango LT5106-T ophthalmic laser (not sold in USA) Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Alcon 3000LE ophthalmic laser Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Ultra Q LQP3106-U ophthalmic laser Terminated |
HQF | None listed |
| Apr 12, 2011 | Ellex Medical Pty Ltd Ellex Super Q LQP3106 ophthalmic laser Terminated |
HQF | None listed |
| Sep 30, 2010 | Lumenis, Inc. Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO Terminated |
HQF | None listed |
| Sep 11, 2010 | Peregrine Surgical Ltd Peregrine 20 GA Endo Ocular Adjustable Laser Probe Terminated |
HQF | None listed |
| May 28, 2010 | Bausch & 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 |
HQF | K033941 |
| Jan 20, 2010 | Ellex Medical Pty Ltd Motorised Safety Filter, Wild; Model number 6339590.
Intended for photocoagulation. Terminated |
HQF | None listed |
| Jan 20, 2010 | Ellex Medical Pty Ltd Ellex Motorised Safety Filter, Zeiss; Model number 6339585.
Intended for photocoagulation. Terminated |
HQF | None listed |
| Nov 6, 2008 | Alcon 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 |
HQF | None listed |
| Dec 20, 2007 | Ellex 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 |
HQF | K052777 |
| Dec 20, 2007 | Ellex USA Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. Terminated |
HQF | K041598 |
| Jul 20, 2004 | Alcon Research, Ltd. Opthalmic Laser, product number 8065-5000-1 Terminated |
HQF | None listed |
| Dec 17, 2003 | LightMed USA Inc Model LightLas 532 Opthalmic Photocoagulator Laser Terminated |
HQF | K010372 K990075 |
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