ADVANCED CONCEPT INNOVATIONS LLC

FDA Device Registration & Listing · LAKELAND, FL, US · Registration 3006015326

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006015326
FEI Number
3006015326
Entity Name
ADVANCED CONCEPT INNOVATIONS LLC
City/State/Country
LAKELAND, FL, US
Establishment Address
4100 S. FRONTAGE RD., Suite 104, LAKELAND, FL 33815, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ADVANCED CONCEPT INNOVATIONS LLC (Owner Number: 9094662)
Owner / Operator Contact Address
4100 S. FRONTAGE RD., ste 104, Lakeland, FL 33815, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K073485
PMA Number
N/A

All Registered Proprietary Names

Tampon, Menstrual, Unscented SUREVUE ACUVUE CLEAR ACUVUE ACUVUE 3 Freedom Knee Freedom Knee Freedom Knee ACUVUE BIFOCAL 1-DAY ACUVUE MOIST (MULTIFOCAL) ACUVUE ADVANCE ACUVUE ADVANCE PLUS ACUVUE ADVANCE for ASTIGMATISM Always Discreet Pads, Scented Menstrual Tampon, Menstrual, Scented, Deodorized ACUVUE 2 DEFINE ACUVUE 2 COLOURS 1-DAY ACUVUE DEFINE Freedom Knee NBX - NON BRIDGING EXTERNAL FIXATOR HAND Freedom Knee The Freedom Total Knee System NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER NBX - NON BRIDGING EXTERNAL FIXATOR HAND Nipple Shield Freedom Knee ACUVUE OASYS ACUVUE OASYS for ASTIGMATISM ACUVUE OASYS for PRESBYOPIA NBX - NON BRIDGING EXTERNAL FIXATOR WRIST ACI Surgical N95 Respirator Freedom Knee Feminine Pads ACUVUE OASYS ACUVUE OASYS for ASTIGMATISM ACUVUE OASYS ACUVUE OASYS for PRESBYOPIA ACUVUE OASYS with HydraLuxe 1-DAY ACUVUE DEFINE with LACREON 1-DAY ACUVUE MOIST 1-DAY ACUVUE MOIST with LACREON 1-DAY ACUVUE MOIST for ASTIGMATISM 1-DAY ACUVUE MOIST for ASTIGMATISM with LACREON SiteSeal Femoral Compression Device 1-DAY ACUVUE TruEye (narafilcon A)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFW Toothbrush, Manual Dental Class 1 872.6855 2012-02-03
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2015-09-14
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-12-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-22
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2016-05-19
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2016-05-19
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2015-09-18
HHL Pad, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5425 2015-09-14
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2015-09-14
HIL Tampon, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5460 2015-09-14
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2016-05-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-22
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-12-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2010-01-04
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2014-09-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-09-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-09-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2014-09-05
NXH Nursing Pad, Cohesive Gel General Hospital Class 1 880.5630 2015-09-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-22
LPM Lenses, Soft Contact, Extended Wear Ophthalmic Class 3 886.5925 2016-05-19
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2021-12-22
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-12-22
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2021-05-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-22
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2015-09-11
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2019-01-29
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2019-01-29
MVN Lens, Contact, (Disposable) Ophthalmic Class 2 886.5925 2016-05-19
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2022-08-10
LPL Lenses, Soft Contact, Daily Wear Ophthalmic Class 2 886.5925 2016-05-19

Official Correspondent

Matthew Muller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ADVANCED CONCEPT INNOVATIONS 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
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K923985 Personal Products Co. UNSCENTED MENSTRUAL TAMPON 1993-02-19
K151170 Tosama, D.O.O. Tosama 100% Organic Cotton Menstrual Tampon 2015-07-02
K930149 Kimberly-Clark Corp. KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ 1994-03-02
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

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 3006015326. Last updated year: 2026. Please use registration number 3006015326 when referencing this establishment in official correspondence.
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