Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015533540

FEI Number

3015533540

Entity Name

ELEVATE SOLUTIONS GROUP, LLC

City/State/Country

Austell, GA, US

Establishment Address

7900 Troon Circle SW, Austell, GA 30168, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Elevate Solutions Group, LLC (Owner Number: 10058417)

Owner / Operator Contact Address

7900 Troon Circle SW, Austell, GA 30168, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151918

PMA Number

N/A

All Registered Proprietary Names

Alcon Opthalmic Flipper Lens Ultra Sample Kits VTI Sample Kits Alcon Opthalmic Flipper Handle BioTrue Sample Kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2021-04-30
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2020-02-13
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2018-09-22
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2018-09-22
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2021-04-30
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-02-13
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-02-13

Official Correspondent

Michael Shippel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elevate Solutions Group, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015533540. Last updated year: 2026. Please use registration number 3015533540 when referencing this establishment in official correspondence.