INTACS CORNEAL IMPLANTS
ADDITION TECHNOLOGY
ADDITION TECHNOLOGY, INC.
FDA Registration(s)#
| 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 | 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 |
|---|---|---|
| LQE | 1 | 1999-04-09 |
PMA#
INTACS CORNEAL IMPLANTS
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS
ADDITION TECHNOLOGY
INTACS CORNEAL RING SEGMENTS
ADDITION TECHNOLOGY
INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
ADDITION TECHNOLOGY
INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
ADDITION TECHNOLOGY
INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
ADDITION TECHNOLOGY
GUDID#
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2023-06-13
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.
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.
2015-06-30