Identity
- Trade Name
- Envision System FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- AG609993A FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- AG609993A FDA UDI
- Primary DI / UDI-DI
- 07290016633726 FDA UDI
- FDA Product Code
- GEX FDA UDIGEI FDA UDIONF FDA UDINUV FDA UDIISA FDA UDIPBX FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI878.4400 FDA UDI890.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
Envision System by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200293 also covers:
K210492 also covers:
- APEX RF System — Inmode MD , Ltd.
- ApexRF Applicator — Inmode MD , Ltd.
- CelluTite System — Inmode MD , Ltd.
- EMPOWER ENVISION — Inmode MD , Ltd.
- EmPowerRF platform — Inmode MD , Ltd.
- FRACTORA 3D-90 Tip — Inmode MD , Ltd.
- FormaI — Inmode MD , Ltd.
- Luxora System — Inmode MD , Ltd.
- Morpheus8 TIP — Inmode MD , Ltd.
- Morpheus8C Handpiece — Inmode MD , Ltd.
K221571 also covers:
- Diolaze XL 755/810 Applicator — Inmode MD , Ltd.
- Diolaze XL 810 Applicator — Inmode MD , Ltd.
- Diolaze XL 810/1064 Applicator — Inmode MD , Ltd.
- Diolaze XL Max Applicator — Inmode MD , Ltd.
- FRACTORA 3D-90 Tip — Inmode MD , Ltd.
- FormaV Applicator — Inmode MD , Ltd.
- Fusion Dark Applicator — Inmode MD , Ltd.
- Fusion Light Applicator — Inmode MD , Ltd.
- InMode OP — Inmode MD , Ltd.
- Lumecca I — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI 36dcd371-96b9-45e0-a60b-ff109787b8ed 36 fields · synced May 30, 2026