Data / Medical devices / United States / Paragon Vision Sciences, Inc.

Paragon Vision Sciences, Inc.: FDA-registered device maker in Gilbert, AZ, United States, 3 510(k) clearances and 3 PMA approvals

Name: Paragon Vision Sciences, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Paragon Vision Sciences, Inc. is registered with the FDA (registration 3013398957) in Gilbert, AZ, United States. It lists 5 device types. The FDA files 3 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 5, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Paragon Vision Sciences, Inc.

FDA registration number: 3013398957
Address: 2120 W. Guadalupe Rd., Gilbert, AZ, United States, 85233
Owner or operator: COOPERVISION, INC. (9929062)
Roles: Complaint file establishment, Manufacturer
First device listed: December 22, 2017
Registered through: 2026
Brand names listed: Acuity 100 with Tangible Hydra-PEG, Contact Lens Storage Case, FluoroPerm151, FluoroPerm30, FluoroPerm60, FluoroPerm92, HDS, HDS100 and more

Devices it lists

Device	Product code	Class	Role	Source
Case, Contact Lens	LRX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lens, Contact (Other Material) - Daily	HQD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lens, Contact (Polymethylmethacrylate)	HPX	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lens, Contact (Rigid Gas Permeable), Extended Wear	MWL	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 5, 2023	K221768	Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	HQD	Substantially Equivalent	Paragon Vision Sciences, Inc.	accessdata.fda.gov
March 16, 2018	K180172	FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG	HQD	Substantially Equivalent	Paragon Vision Sciences	accessdata.fda.gov
June 12, 2003	K030987	CONTACT LENS STORAGE CASE	LRX	Substantially Equivalent	Pelican Products	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
November 16, 2006	P050031	PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY	NUU	7	May 10, 2022	accessdata.fda.gov
December 31, 1987	P870024	FLUOROPERM RGP CONTACT LENSES	MWL	56	June 16, 2022	accessdata.fda.gov
December 23, 1983	P820063	PARAPERM O2 CONTACT LENS	HPX	46	January 4, 1994	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 26, 2023	92719	Class II	Ongoing	ISee Ortho-K Lens	Manufactured lenses are not covered by existing FDA approval	accessdata.fda.gov

Compare with other makers

Updated September 5, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.