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Lasik Eye Drape

by Odyssey Medical, Inc.

510(k) K042977

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042977 Date10 May 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lasik Eye Drape is a sterile, single-use surgical drape designed to create a sterile barrier during ophthalmic procedures, including LASIK. It is composed of medical-grade polyethylene tape with a pressure-sensitive acrylate adhesive that drapes the eyebrow, eye perimeter, or eyelids to retract eyelashes from the visual field.

This device is supplied as a single-use product intended for use in ophthalmic surgery. It is applied by preparing and draping the patient in the standard ophthalmic fashion to hold back eyelashes as required. This device has received FDA 510(k) clearance.

Other devices from Odyssey Medical, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Lasik Eye Drape?

    This device is designed to create a sterile barrier during ophthalmic procedures, specifically LASIK. It functions by draping the eyebrow, eye perimeter, or eyelids to effectively retract eyelashes from the visual field.

  • Is this drape intended for multiple uses?

    No, the Lasik Eye Drape is strictly a single-use product. It is supplied as a sterile device intended to be used once per patient to maintain hygiene and safety standards during ophthalmic surgery.

  • What materials are used in the construction of this drape?

    The drape is composed of medical-grade polyethylene tape. It features a pressure-sensitive acrylate adhesive that allows it to be applied to the skin around the eye to hold back eyelashes as required during the procedure.

  • What is the regulatory status of this device?

    The Lasik Eye Drape has received FDA 510(k) clearance under K042977. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices for the same intended use.