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Lucent IPL ESM-9200IL

by Luvo Medical Technologies Inc

Lucent IPL ESM-9200IL is a Class II device made by Luvo Medical Technologies Inc, cleared under FDA 510(k) K193072 on 5 Mar 2020 and listed in FDA GUDID since 1 Jun 2021 (UDI-DI 00754016214004), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K193072

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00754016214004 UDI-DI Date1 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193072 Date5 Mar 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193072 decided 5 Mar 2020 Active
  • FDA GUDID UDI-DI 00754016214004 listed 1 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193072
  2. Listed FDA GUDID 00754016214004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lucent IPL
Generic name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / reference
ESM-9200IL
Primary DI / UDI-DI
00754016214004
510(k) Number
FDA product code
ONF
GMDN term
Musculoskeletal infrared phototherapy unit, non-wearable
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

Other devices from Luvo Medical Technologies Inc

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)