Data / Medical devices / United States / ABB Optical Group LLC.
ABB Optical Group LLC.: FDA-registered device maker in Kansas City, MO, United States, 9 510(k) clearances and 1 PMA approval
ABB Optical Group LLC. is registered with the FDA (registration 2916547) in Kansas City, MO, United States. It lists 1 device type. The FDA files 9 510(k) clearances and 1 PMA approval under its listings, the newest dated December 10, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2916547
- Address
- 3901 Ne 33rd Ter Ste E, Kansas City, MO, United States, 64117
- Owner or operator
- ABB OPTICAL GROUP, LLC (10036093)
- Roles
- Manufacturer
- First device listed
- April 19, 2011
- Registered through
- 2026
- Brand names listed
- CONCISE, Concise Custom Soft Contact Lens
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 10, 2002 | K023077 | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| April 26, 2002 | K020690 | OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| June 19, 2001 | K011577 | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| February 21, 2001 | K004000 | OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| February 21, 2001 | K003996 | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| November 8, 2000 | K002966 | OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| October 4, 1999 | K992466 | OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| March 25, 1996 | K960291 | TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS | LPL | Substantially Equivalent | Ocu-Ease Optical Products, Inc. | accessdata.fda.gov |
| October 13, 1994 | K941998 | OCU-FLEX-38 (POLYMACON) | LPL | Substantially Equivalent | Ocu-Ease Optical Products, 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 |
|---|---|---|---|---|---|---|
| February 20, 1986 | P820051 | OCU-FLEX | LPL | 8 | February 26, 1993 | accessdata.fda.gov |
Compare with other makers
Updated December 10, 2002. 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.