Atlas FDA

OLI

33 FDA 510(k) clearances · Product code

108 daysmedian time to decision
297 days90th percentile
33clearances measured

FDA profile

Official device name
Fat Reducing Low Level Laser
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5400
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
FDA definition
Non-invasive reduction in fat layer for body contouring
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RecordFirmDate
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (K260688)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-05-04
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (K260129)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-04-15
Contour Light (CL-100) (K243854)Contour Research, LLC2026-02-13
Erchonia CLX (Model # CFL) (K252574)Erchonia Corporation2025-12-15
Led Light Phototherapy Bed (Pro 450/ GY-680A) (K252786)Shenzhen Suyzeko Limited.2025-12-01
Erchonia Zerona® VZ8 (K243811)Erchonia Corporation2025-01-10
Biophotas Celluma CONTOUR (K232977)Biophotas, Inc.2023-11-21
Erchonia Violet ZERONA® Z6 OTC (K231474)Erchonia Corporation2023-07-21
Erchonia Zerona Z-Bed (K220519)Erchonia Corporation2022-03-24
PHantom Trilogy (K213534)Resurgeonz, LLC2022-03-11
Contour Light CL-100 (K202955)Contour Research, LLC2021-05-19
UltraSlim Digital, UltraSmooth Digital (K202361)Ward Photonics, LLC2020-12-18
invisa-RED ELITE (K192275)IR Technology, LLC2020-08-19
Erchonia Emerald (K192544)Erchonia Corporation2020-01-13
Cellulize (K180338)Ward Photonics, LLC2018-09-21
Vevazz LED (K172111)Vevazz, LLC2017-11-22
CURVE Laser System (K170709)Yolo Medical, Inc.2017-06-06
Zerona Z6 OTC (K162578)Erchonia Corporation2016-12-16
Photonica Professional (K160880)Ward Photonics, LLC2016-09-23
Erchonia Zerona 6 headed scanner EZ6 (K150446)Erchonia Corporation2015-05-21
Lipofina Laser System (K143741)Yolo Medical, Inc.2015-04-24
Erchonia Zerona Z6 OTC (K143007)Erchonia Corporation2015-01-15
ERCHONIA SHL (K142042)Erchonia Corporation2014-10-21
BTL-9000; BTL-9000 RADIOFREQUENCY MODULE (K134040)Btl Industries, Ltd.2014-09-10
ZERONA (K133718)Erchonia Corporation2014-05-12
STRAWBERRY, STRAWBERRY & CREAM (K130341)Laser Lipo Limited2013-09-06
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER (K130922)Erchonia Medical, Inc.2013-05-17
ZERONA 2.0 LASER (K123237)Erchonia Corporation2013-01-25
ERCHONIA ZERONA (K121695)Erchonia Corporation2012-08-23
ETCHONIA ZERONA ARMS (K121690)Erchonia Corporation2012-08-23
MLS, ZERONA-AD (K120257)Erchonia Medical, Inc.2012-05-14
I-LIPO SYSTEM (K111501)Chromogenex Technologies Limited2012-03-23
ERCHONIA ML SCANNER (MLS) (DEN090008)Erchonia Medical2010-08-24

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Every clearance here is in the API, with alerts when new ones post.