Envision System

Basic Information

• Brand Name: Envision System
• Primary DI: 07290016633726
• Version / Model: AG609993A
• Catalog Number: AG609993A
• Company Name: INMODE M.D LTD
• Labeler DUNS: 600417351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-24
• Public Version: 2
• Public Version Date: 2025-05-07
• Public Version Status: Update
• Public Device Record Key: 36dcd371-96b9-45e0-a60b-ff109787b8ed

Device Description

The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aesthetic applications – Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Forma-I and Forma Handpieces employs bi-polar Radiofrequency (RF) technology for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation; Lumecca IPL for treatment of superficial vascular and pigmented lesions; and Morpheus8 for electro-coagulation. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.

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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	878.4810	2
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	878.4810	2
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	878.4400	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	07290016633726	GS1

Premarket Submissions

Submission Number	Supplement Number
K200293	000
K210492	000
K221571	000

Storage Conditions

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