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XE-LITE

by Ophthalmic Technologies, Inc.

510(k) K954263

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)SESD Substantially Equivalent — Deferred · Traditional NumberK954263 Date18 Oct 1995ClearedStatusActive

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  • Withdrawn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
FTD
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESD Substantially Equivalent — Deferred

Overview

AI-generated summary, 21 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 XE-LITE is a surgical lamp designed for use in medical procedures. It is classified as a Class II medical device and is intended for illumination during surgical operations.

The device is supplied as a single-use item and is not reusable. It is not MRI safe and should be stored in a dry environment. The XE-LITE has received FDA 510(k) clearance for use in general and plastic surgery procedures.

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