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Erchonia PL Touch

by Erchonia Corporation

510(k) K153052

Erchonia PL Touch is a Class II device made by Erchonia Corporation, cleared under FDA 510(k) K153052 on 4 Jan 2016, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK153052 Date4 Jan 2016ClearedStatusActive

Official records

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  • Withdrawn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
NHN
Device class
Class II
Regulation
21 CFR Part 890.5500
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Devices cleared under K153052

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K153052
UDI-DISize and differences
PL Touch PLT
Erchonia Corporation
PLT / PLT00858985006063 —On the market

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Other devices filed under FDA product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy).

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