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Medx Lpt 200 Tethered Laser & Medx Lps 200 (Oralase) Portable Laser

by Medx Electronics, Inc.

510(k) K082707

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 NumberK082707 Date1 Oct 2008ClearedStatusActive

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  • Withdrawn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
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER is a device that includes a single diode tethered laser and a portable laser system, designed as part of an infrared console system. It utilizes an infrared GaAlAs laser diode with three visible red guide LEDs and features interchangeable light guides for intra- or extra-oral access.

The device is indicated for use when heat is indicated for temporary increase in local blood circulation and temporary relief of minor muscle and joint discomfort. It is supplied as a portable laser system and has received FDA 510(k) clearance under K082707, with product code ILY and review by the Physical Medicine advisory committee.

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