Identity
- Trade Name
- Plus Applicator FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system applicator FDA UDI
- Device Name
- Plus (Plus Plus) FDA UDI
- Model / Reference
- AS601679A FDA UDI
- Description
- Plus (Plus Plus) FDA UDI
Identifiers
- Catalog Number
- AS601679A FDA UDI
- Primary DI / UDI-DI
- 07290016633313 FDA UDI
- FDA Product Code
- GEI FDA UDIGEX FDA UDIONF FDA UDIPBX FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 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: Radio-frequency skin surface treatment system applicator
Plus Applicator 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
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.
- Envision System — 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.
K251632 also covers:
- Diolaze XL Max Applicator — Inmode MD , Ltd.
- Fusion Dark Applicator — Inmode MD , Ltd.
- Fusion Light Applicator — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
- Morpheus8 24 pin TIP — Inmode MD , Ltd.
- Morpheus8 40 pin TIP — Inmode MD , Ltd.
- Morpheus8 Burst Applicator — Inmode MD , Ltd.
- Morpheus8 Burst Deep Applicator — Inmode MD , Ltd.
- Morpheus8 Prime 12 pin TIP — Inmode MD , Ltd.
- Morpheus8 Resurfacing TIP — Inmode MD , Ltd.
- OptimasMax platform — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI 339de29c-dca5-43c7-b067-41980fdfa6af 37 fields · synced May 30, 2026