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Elevate Solutions Group, LLC: FDA-registered device maker in Austell, GA, United States, 3 510(k) clearances and 1 PMA approval

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

Elevate Solutions Group, LLC is registered with the FDA (registration 3015533540) in Austell, GA, United States. It lists 5 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated June 2, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015533540
Address: 7900 Troon Circle SW, Austell, GA, United States, 30168
Owner or operator: Elevate Solutions Group, LLC (10058417)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: September 22, 2018
Registered through: 2026
Brand names listed: Alcon Opthalmic Flipper Handle, Alcon Opthalmic Flipper Lens, BioTrue Sample Kits, Infuse Spherical, Multifocal, and Toric (kalifilcon A) One-Day Soft Hydrophilic Contact Lens Sample Kits, Ultra Sample Kits, VTI Sample Kits

Devices it lists

Device	Product code	Class	Role	Source
Frame, Trial, Ophthalmic	HPA	1	Contract manufacturer	accessdata.fda.gov
Lens, Contact, (Disposable)	MVN	2	Repackager or relabeler	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Repackager or relabeler	accessdata.fda.gov
Lenses, Soft Contact, Extended Wear	LPM	3	Repackager or relabeler	accessdata.fda.gov
Set, Lens, Trial, Ophthalmic	HPC	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
June 2, 2020	K200528	Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism	LPL	Substantially Equivalent	Bausch + Lomb, Incorporated	accessdata.fda.gov
November 7, 2017	K173086	NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses	LPL	Substantially Equivalent	Visioneering Technologies, Inc.	accessdata.fda.gov
February 11, 2016	K151918	Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	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
April 30, 2018	P170035	Bausch + Lomb Ultra (samfilcon A) Contact Lenses	LPM	18	September 14, 2026	accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. 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.