Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010511300

FEI Number

3010511300

Entity Name

INMODE LTD.

City/State/Country

Yokneam Northern, IL

Establishment Address

Tavor Building (POB 533), Shaar Yokneam, Yokneam Northern 2069206, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INMODE LTD. (Owner Number: 10045478)

Owner / Operator Contact Address

Tavor Building (POB 533), Shaar Yokneam, Yokneam, IL-Z 2069206, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201150

PMA Number

N/A

All Registered Proprietary Names

InMode Diolaze XL TRITON/ OPTIMAS (system platform) DEFINE InMode System with the Morpheus8 90 Applicator InMode System with the Morpheus 8 Applicators Morpheus 8 PRIME Tip (12 Pin Applicator) Morpheus 8 BODY Tip (40 Pin Applicator) Morpheus 8 T Tip InMode System with the vTone Applicator EMPOWER RF System (System platform) EVOLVE System with the Tone Applicator SR IPL Device LUMECCA 515 LUMECCA 580 OPTIMAS (system platform) T3 Applicator EVOLVE X (Platform system) Transform (T3 Applicator) EVOLVE (Platform system) InMode System with Tone Applicator InModeRF Applicator InModeRF HP101306A Applicator EMBRACE/InModeRF (system platform) The Evolve System with the Transform Applicator WMBody BodyFX CONTOURA/ OPTIMAS (system platform) FORMA LUMECCA 580 PEAK DiolazeXL MAX 810 Fusion Light 755/810 OptimasMAX System LUMECCA 515 PEAK Fusion Dark 810/1064 MORPHEUS8 DEEP MORPHEUS8 VascuLazeMAX PLUS WMFace Forma CONTOURA/ OPTIMAS (system platform) InMode RF System HP1022B6A HP2539B6A HP172246A HP101306A QUANTUMRF 10 HP102206A HP101396A INMODE RF PRO (System platform) HP172248A FACETITE TURBO HP172206A HP253966A IgniteRF HP060999A HP060909A QUANTUMRF 25 Luxora BODYTITE TURBO HP172296A vTone InMode Multi System Fusion Dark InMode OP VasculazeMAX Fusion Light OptimasMAX OptimasMAX platform LUMECCA I Envision DiolazeXL MAX LUMECCA PEAK Optimas Fractora Fractora 60P Morphiva (InMode Fractora 3D-90 Applicator) InMode System With Fractora3D/3D-90 Applicators CONTOURA/ OPTIMAS (system platform) Morpheus (InMode Fractora 3D Applicator) Morpheus V (InMode Fractora 3D-90 Applicator & Tip) InMode PLUS System CONTOURA/ OPTIMAS (system platform) InModeRF HP172248A Applicator InModeRF HP173946A Applicator InModeRF HP172246A Applicator BodyTite EMBRACE InModeRF Aviva AccuTite EMBRACE (System platform) InMode RF PRO (System platform) InMode RF (System platform) BodyTite Pro Votiva InMode RF PRO (System Platform) Forma-i Applicator iForma Applicator ENVISION (System platform) i-Forma Applicator EMPOWER (System platform) CellulTite system Cellutite APEX RF (System platform) Luxora Morpheus8C Handpiece APEX RF Applicator EMFace EVOKE DEFINE InMode Diolaze XL (system platform) InMode Diolaze XL 810nm Hand piece (FDA cleared in K170738) InMode Diolaze XL 755/810nm Hand piece InMode Diolaze XL 810/1064nm Hand piece TRITON/ OPTIMAS (system platform) InMode System MiniFX Handpiece CONTOURA/ OPTIMAS (system platform) DIOLAZE Hair Removal (HR) Device EmBodyFX TI10 Evolve Trim EmBodyPlus EmBody System Vasculaze InMode VLaze TRITON/ OPTIMAS (system platform) InMode System with the Morpheus8 Applicators Morpheus8 Resurfacing 24 pin Luxora Morpheus8 Morpheus8 24 pin Morpheus8 Prime 12 pin Morpheus8 Deep Morpheus8 40 pin EMPOWER (System platform) InMode RF Multi-System Votiva CONTOURA Morpheus Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-08-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-09
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2024-12-09
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-12-09
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2024-12-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-29
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2020-05-06
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-03-07
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-03-07
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2013-11-21
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-07-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-07-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2021-07-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2019-12-18
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2019-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-03-19
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2013-11-21
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2013-11-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-30
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-06-30
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-06-30
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2025-06-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-03-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-05
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2017-08-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-07-01
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-07-01
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-07-01
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-07-01
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-07-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-09-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-06-06
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-01-02
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2018-01-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-02-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-07-13
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-07-13
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2021-07-13
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2021-07-13
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-11-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-06-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-07
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2016-09-07
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-11-21
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2019-06-24
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-06-24
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-06-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-02-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-03-19
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2020-07-23
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2020-07-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-23
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2020-07-23

Official Correspondent

No official correspondent registered.

US Agent Details

Naphtali Deutsch Business: A.Stein Regulatory Affairs Consulting Company Ltd. Email: ahava@asteinrac.com Phone: (888) 4433867

Related Public Records

Same Entity

INMODE LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010511300. Last updated year: 2026. Please use registration number 3010511300 when referencing this establishment in official correspondence.