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Zerona

by Erchonia Corporation

510(k) K133718

Zerona is a Class II device made by Erchonia Corporation, cleared under FDA 510(k) K133718 on 12 May 2014, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133718 Date12 May 2014ClearedStatusActive

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  • Withdrawn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
OLI
Device class
Class II
Regulation
21 CFR Part 878.5400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code OLI (Fat Reducing Low Level Laser).

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  • Zerona 2.0 GLS

    Class II

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    Class II

See all devices from Erchonia Corporation →