Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HQD — Predicate Candidate Screening

118 FDA 510(k) clearances under this product code; the 50 most recent screened below.

88 daysmedian FDA review time

203 days90th percentile

118clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253822	GPA (hexafocon A) Rigid Gas Permeable Contact Lenses	Zhuhai Fitlens Medical Technology Co., Ltd.	2026-03-27	119	0
K242393	Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) wi	Acuity Polymers, Inc.	2024-11-01	80	0
K241398	SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contac	Tianjin Mastervision Technology Co., Ltd.	2024-10-22	159	0
K241571	BostonSight® Specialty Lenses	Boston Foundation For Sight, Inc. D/B/A Bostonsight	2024-08-14	75	0
K240618	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Le	Acuity Polymers, Inc.	2024-04-03	29	0
K233325	Visionary Optics Scleral Contact Lens (roflufocon D, roflufo	Visionary Optics, LLC	2024-02-21	145	0
K230910	NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily	Acculens, Inc.	2023-06-16	77	0
K230965	Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-9	Acuity Polymers, Inc.	2023-06-16	72	0
K221768	Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	Paragon Vision Sciences, Inc.	2023-05-05	322	0
K223394	Visionary Optics Scleral Contact Lens (roflufocon D, roflufo	Visionary Optics, LLC	2022-12-07	29	0
K212631	Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses	Contamac, Ltd.	2022-03-17	210	0
K213880	Custom Stable Rigid Gas Permeable Scleral Contact Lens	Valley Contax, Inc.	2022-01-07	25	0
K213538	Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid G	Acuity Polymers, Inc.	2021-12-30	52	0
K202860	Valley Contax Single Vision (SV) Gas Permeable Contact Lens	Valley Contax, Inc.	2021-05-11	225	0
K203571	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Len	Acuity Polymers, Inc.	2021-04-09	123	0
K201194	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Le	Acuity Polymers, Inc.	2020-09-08	127	0
K183167	Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; B	Bausch & Lomb, Incorporated	2019-02-12	89	0
K183175	BostonSight Scleral	Bostonsight	2019-01-04	49	1
K182304	Hyper GP (tisilfocon A) Daily Wear Contact Lens	Contamac, Ltd.	2018-11-23	91	0
K181579	eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens	E&E Optics, Inc.	2018-07-26	41	0
K180988	Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, A	Acuity Polymers, Inc.	2018-06-08	53	0
K180616	OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact L	Contamac, Ltd.	2018-04-25	48	0
K180172	FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lens	Paragon Vision Sciences	2018-03-16	53	0
K171575	ENFLU 18 (enflufocon A) Daily Wear Contact Lens	Contamac, Ltd.	2017-10-24	147	0
K172314	Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafo	Art Optical Contact Lens, Inc.	2017-09-20	50	0
K171950	Visionary Optics Scleral Contact Lens (roflufocon D, roflufo	Visionary Optics, LLC	2017-08-16	48	0
K171077	HEXA100 (hexafocon A) Daily Wear Contact Lenses	Contamac, Ltd.	2017-08-01	112	0
K171404	BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)	Bausch + Lomb, Incorporated	2017-07-17	66	0
K170001	Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2017-06-02	150	0
K170007	Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2017-05-31	148	0
K170335	Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens	Valley Contax, Inc.	2017-03-24	50	0
K163254	Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2017-01-18	58	0
K162005	Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2016-12-08	141	0
K153714	SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily	Synergeyes, Inc.	2016-11-15	327	0
K161100	Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wea	Contamac, Ltd.	2016-08-10	113	0
K160938	SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A)	Synergeyes, Inc.	2016-08-01	119	0
K161461	BostonSight PD Prosthetic Device	Bostonsight	2016-07-25	60	1
K152724	EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES	Advanced Vision Technologies	2016-04-27	218	0
K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	Boston Foundation For Sight	2016-02-09	110	0
K142510	UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth	Synergeyes, Inc.	2014-11-19	72	0
K120996	FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUO	Paragon Vision Sciences	2012-06-28	87	0
K113586	SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTAC	Synergeyes, Inc.	2012-04-18	135	0
K103561	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	Menicon Co, Ltd.	2011-02-03	59	0
K102154	TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE	The Lagado Corp.	2011-01-21	175	0
K083921	SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTAC	Synergeyes, Inc.	2009-05-20	140	0
K082799	HDS HI 1.54	Paragon Vision Sciences	2009-01-27	126	0
K081178	OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DA	Contamac, Ltd.	2008-10-09	167	0
K081443	MENICON Z RIGID GAS PERMEABLE CONTACT LENS	Menicon Co, Ltd.	2008-09-23	124	0
K081034	SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M,	Synergeyes, Inc.	2008-05-30	49	0
K080193	SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR	Synergeyes, Inc.	2008-03-05	40	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda