Panels › Ophthalmic › Product code HQB · Class 2

Photocoagulator And Accessories

Regulation 886.4690

0510(k)s in 12 months (30 all time)

4recalls in 12 months (32 all time)

4recalls that name a 510(k)

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Top companies in HQB

Company	510(k)s	Recalls
Synergetics, Inc.	1	28
Nidek Co., Ltd.	5	0
Vortex Surgical, Inc.	2	3
Gamp & Assoc.	3	0
Peregrine Surgical , Ltd.	3	0
Alcon Research, Ltd.	1	1
Cavitron Corp.	2	0
Surgical Laser Technologies, Inc.	2	0
Varian Assoc., Inc.	2	0
Advanced Surgical Products, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Feb 4, 2026	Vortex Surgical Inc. Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. Open, Classified	HQB	K220263
Feb 4, 2026	Vortex Surgical Inc. Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat Open, Classified	HQB	K220263
Dec 30, 2025	Vortex Surgical Inc. Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; Open, Classified	HQB	K220263
Nov 21, 2025	Alcon Research LLC CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK Open, Classified	HQB	K110951
Jan 30, 2014	Synergetics Inc 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, M Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed
Jan 30, 2014	Synergetics Inc Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. Terminated	HQB	None listed

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