Data / Medical devices / United States / Zonedin Vision LLC

Zonedin Vision LLC: FDA-registered device maker in McAllen, TX, United States, 7 510(k) clearances

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

Zonedin Vision LLC is registered with the FDA (registration 3016009612) in McAllen, TX, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016009612
Address: 5801 N 10th St #100, McAllen, TX, United States, 78504
Owner or operator: ZonedIn Vision, LLC (10061388)
Roles: Repackager or relabeler
First device listed: October 14, 2019
Registered through: 2026
Brand names listed: Zonedin 47 Sihy, zonedin 55 monthly contact lens, zonedin 58 daily disposable contact lens, zonedin 58 monthly contact lens

Devices it lists

Device	Product code	Class	Role	Source
Lens, Contact, (Disposable)	MVN	2	Repackager or relabeler	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Repackager or relabeler	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Repackager or relabeler	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
April 17, 2024	K240519	Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens	LPL	Substantially Equivalent	Innova Vision, Inc.	accessdata.fda.gov
November 16, 2023	K232139	Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens	LPL	Substantially Equivalent	Innova Vision, Inc.	accessdata.fda.gov
May 16, 2019	K182734	Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac	LPL	Substantially Equivalent	Unicon Optical Co., Ltd.	accessdata.fda.gov
April 8, 2016	K153766	Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear	LPL	Substantially Equivalent	INTEROJO, Inc.	accessdata.fda.gov
June 22, 2015	K141348	VISCO SOFT CONTACT LENS	LPL	Substantially Equivalent	Visco Vision, Inc.	accessdata.fda.gov
October 17, 2014	K141917	UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR	LPL	Substantially Equivalent	Unicon Optical Co., Ltd.	accessdata.fda.gov
September 3, 2009	K083288	DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER	LPL	Substantially Equivalent	Innova Vision, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2024. 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.