ADDITION TECHNOLOGY, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2953726	3000309468	ADDITION TECHNOLOGY, INC.	1	N	2026-01-01	820 Oak Creek Dr Lombard IL US 60148

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
68173	1710000055	P980031	INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS	LQE	1999-04-09
68173	1893399093	H040002
68173	1173680346
68173	1257493217
68173	1296732851
68173	1322911704
68173	1381252843
68173	1722303736
68173	1734080192

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LQE	1	1999-04-09

GUDID#

Intacs Corneal Separator, CW, 0.9mm - The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within the cornea.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Corneal Separator, CCW, 0.9mm - The Corneal Separators are composed of a stainless-steel tubular body with a 210° blade attached to the body by a spoke. Each Corneal Separator is inserted through the 0.9 mm entry incision to create either a CW or a CCW annular subsurface tunnel. The Corneal Separators are designed for use with the Vacuum Centering Guide (VCG). Each Corneal Separator is designed to slide easily into the VCG and to rotate smoothly through the stroma to precisely create the CW and CCW intrastromal tunnels within the cornea.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Inspection Gauge - The Inspection Gauge, 0.9 mm is used as a reference to inspect the concentricity and planarity of the 0.9 mm CW and CCW Corneal Separators prior to each Intacs Corneal Implants surgery.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Procedure Marker - The Procedure Marker, 0.9 mm is used for marking the 1.2 mm incision and the placement marks for the 150 degree Intacs® Corneal Implants by aligning the reticle with the center mark that has been created on the cornea. This multi-functional device is also used later in the surgical procedure to align the Vacuum Centering Guide on the cornea.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Forceps - Designed to be used in an operating room environment by a surgeon to secure hold and facilitate placement of the INTACS implant.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Vacuum Centering Guide - The Vacuum Centering Guide (VCG) is composed of stainless steel and features a port for attachment to a vacuum source (KV2000 Vacuum System). The VCG functions as a suction ring that is equipped with fins on the bottom to provide for rotational stability and a seating surface for adherence to and stabilization of the eye during the creation of the intrastromal tunnels. The VCG is contoured to allow for a more natural fit under the eye lids and the speculum.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Pocketing Hook - Designed to be used in an operating room environment by a surgeon to delaminate cornea stroma to initiate a pocket on each side of the incision.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Symmetric Glide - The Symmetric Glide is a bifurcated glide instrument that is manufactured from surgical titanium and is inserted into the 1.2 mm entry incision to effectively guide the CW and CCW Corneal Separators into the stromal pocket.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Symmetric 0.210 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Symmetric 0.250 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Symmetric 0.300 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Symmetric 0.350 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Symmetric 0.400 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Symmetric 0.450 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Asymmetric 0.210/0.350 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Asymmetric 0.210/0.400 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Keratoconus, Asymmetric 0.210/0.450 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in asymmetric sizes.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Myopia, Symmetric 0.250 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the correction of myopia without interfering with the patient’s central visual axis. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.250 to 0.350 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Myopia, Symmetric 0.300 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the correction of myopia without interfering with the patient’s central visual axis. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.250 to 0.350 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs for Myopia, Symmetric 0.350 mm - Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the correction of myopia without interfering with the patient’s central visual axis. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.250 to 0.350 mm.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Sterile Vacuum Tubing - Single use disposable vacuum tubing set to be used as an accessory to the Addition Technology, Inc and Kera Vision Vacuum System.
ADDITION TECHNOLOGY, INC.
2023-06-13
Intacs Corneal Implants - An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
2015-06-30