InMode

Basic Information

• Brand Name: InMode
• Primary DI: 07290016633382
• Version / Model: AG606992A
• Catalog Number: AG606992A
• Company Name: INMODE M.D LTD
• Labeler DUNS: 600417351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 2aa84bfe-eb82-42b7-9b38-06f8b2607e77

Device Description

InMode System 2 - color 2 The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45220	Multi-modality skin surface treatment system	An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016633382	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180719	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 110 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 90 – 110 KiloPascal