Data / Medical devices / United States / Advanced Concept Innovations LLC
Advanced Concept Innovations LLC: FDA-registered device maker in Lakeland, FL, United States, 14 510(k) clearances and 2 PMA approvals
Advanced Concept Innovations LLC is registered with the FDA (registration 3006015326) in Lakeland, FL, United States. It lists 20 device types. The FDA files 14 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 10, 2018. 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.
- FDA registration number
- 3006015326
- Address
- 4100 S. FRONTAGE RD. Suite 104, Lakeland, FL, United States, 33815
- Owner or operator
- ADVANCED CONCEPT INNOVATIONS LLC (9094662)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 4, 2010
- Registered through
- 2026
- Brand names listed
- 1-DAY ACUVUE, 1-DAY ACUVUE DEFINE, 1-DAY ACUVUE DEFINE with LACREON, 1-DAY ACUVUE EasyGo, 1-DAY ACUVUE MOIST, 1-DAY ACUVUE MOIST (MULTIFOCAL), 1-DAY ACUVUE MOIST for ASTIGMATISM, 1-DAY ACUVUE MOIST for ASTIGMATISM with LACREON and more
Devices it lists
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 10, 2018 | K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| September 18, 2014 | K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| May 21, 2010 | K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| June 27, 2008 | K081555 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | HIL | Substantially Equivalent | Procter & Gamble Co. | accessdata.fda.gov |
| March 3, 2008 | K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| November 22, 2006 | K062638 | TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS | HEB | Substantially Equivalent | Procter & Gamble Co. | accessdata.fda.gov |
| November 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 4, 2004 | K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| October 16, 2003 | K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| February 26, 2002 | K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 23, 2000 | K994324 | ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPL | Substantially Equivalent | Vistakon, Johnson & Johnson Vision Products, Inc. | accessdata.fda.gov |
| November 30, 1994 | K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | KOO | Substantially Equivalent | Procter & Gamble Co. | accessdata.fda.gov |
| June 19, 1987 | K870066 | KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS | HHL | Substantially Equivalent | Cascades Psh, Inc. | 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 |
|---|---|---|---|---|---|---|
| December 20, 2005 | P040045 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPM | 143 | October 16, 2026 | accessdata.fda.gov |
| March 18, 1980 | N18033 | ACUVUE CONTACT LENS | LPM | 107 | April 17, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Component, Traction, Invasive
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Clamp, Vascular
- All makers of Garment, Protective, For Incontinence
Updated October 16, 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.