Intacs Corneal Implants

FDA UDI

Class III (US FDA UDI)

by Addition Technology

Identity

Trade Name: Intacs Corneal Implants FDA UDI
Generic Name: Intracorneal ring segment FDA UDI
Device Name: 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. FDA UDI
Model / Reference: ICI FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00866304000104 FDA UDI
PMA Number: P980031 FDA UDI
FDA Product Code: LQE FDA UDI
GMDN Term: Intracorneal ring segment FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Intracorneal ring Intracorneal ring segment

Intacs Corneal Implants by Addition Technology — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracorneal ring.

Intacs for Keratoconus, Symmetric 0.250 mm — Addition Technology · Class III
Intacs for Myopia, Symmetric 0.350 mm — Addition Technology · Class III
Intacs for Keratoconus, Symmetric 0.300 mm — Addition Technology · Class III
Intacs for Keratoconus, Symmetric 0.210 mm — Addition Technology · Class III
Intacs for Keratoconus, Asymmetric 0.210/0.400 mm — Addition Technology · Class III
Intacs for Keratoconus, Symmetric 0.350 mm — Addition Technology · Class III
Intacs for Myopia, Symmetric 0.300 mm — Addition Technology · Class III
Intacs for Keratoconus, Symmetric 0.450 mm — Addition Technology · Class III

Cleared under the same submission

P980031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Addition Technology

Sources (1)

FDA UDI 56e74c7d-f31b-4094-b1ed-e139262a4596 34 fields · synced Jun 6, 2026