Identifiers
- 510(k) Number
- K893731 FDA 510(k)
- FDA Product Code
- LQJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shields T.C. Laser Lens is a surgical lens accessory designed for use with ophthalmic lasers. It is classified as a Class II medical device under FDA regulation 886.4390 and is intended for use in ophthalmic procedures requiring laser delivery.
The device was cleared via the FDA 510(k) pathway under K893731 on August 17, 1989, as substantially equivalent to a predicate device. It is manufactured by Ocular Instruments, Inc. and is supplied as a non-sterile, reusable accessory for ophthalmic laser systems.
Frequently asked questions
What is the Shields T.C. Laser Lens used for?
The Shields T.C. Laser Lens is a surgical lens accessory intended for use with ophthalmic lasers in procedures requiring laser delivery, as specified in its FDA 510(k) clearance.
Is the Shields T.C. Laser Lens sterile or non-sterile, and is it reusable?
The Shields T.C. Laser Lens is supplied as a non-sterile, reusable accessory for ophthalmic laser systems, meaning it must be cleaned and sterilized by the user before each use.
What regulatory pathway was used to clear the Shields T.C. Laser Lens?
The Shields T.C. Laser Lens was cleared via the FDA 510(k) pathway under K893731 on August 17, 1989, as substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K893731 | Class II | Active |
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Manufacturer
- Manufacturer
- Ocular Instruments, Inc.
Sources (1)
- FDA 510(k) K893731 24 fields · synced Sep 23, 2026