Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Unilens Corp., USA · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time

122 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K142851	CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Len	Unilens Corp., USA	2014-10-30	30
K121652	CVUE ADVANCED HYDRA VUE	Unilens Corp., USA	2012-10-05	122
K110452	SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BA	Unilens Corp., USA	2011-04-20	63
K100456	CVUE ADVANCED DEFINITIVE	Unilens Corp., USA	2010-10-28	253
K082393	CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LEN	Unilens Corp., USA	2008-09-11	23
K050743	AQUAFLEX 2 (TEFILCON) CONTACT LENS	Unilens Corp., USA	2005-04-13	23
K041608	C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS	Unilens Corp., USA	2004-07-07	22
K002408	AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTR	Unilens Corp., USA	2000-10-17	71
K960926	POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT L	Unilens Corp., USA	1996-04-10	35
K960380	SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS	Unilens Corp., USA	1996-03-28	62
K960376	FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LEN	Unilens Corp., USA	1996-03-28	62
K941836	UNILENS 38 SOFT ASPHERIC CONTACT LENS	Unilens Corp., USA	1994-07-07	85
K942372	SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT L	Unilens Corp., USA	1994-07-07	50
K940777	BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS	Unilens Corp., USA	1994-04-12	49

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