Identity
- Trade Name
- Legato® FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- joimax® Legato-Trigger Flex FDA UDI
- Model / Reference
- JRFCP2300 FDA UDI
- Description
- joimax® Legato-Trigger Flex FDA UDI
Identifiers
- Catalog Number
- JRFCP2300 FDA UDI
- Primary DI / UDI-DI
- 04250337119999 FDA UDI
- 510(k) Number
- K161378 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system generator
Legato® by Joimax, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161378 also covers:
- Endovapor® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Legato® — JOIMAX, INC.
- Vaporace® Hand Piece, bipolar — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 150 mm – 3.5 mm — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 270 mm – 3.5 mm — JOIMAX, INC.
- Vaporace® Probe bipolar, Area 320 mm – 3.5 mm — JOIMAX, INC.
- Vaporace®/Vaporgrip® Kabel, L 3, 0 m — JOIMAX, INC.
- Vaporflex® — JOIMAX, INC.
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
- Joimax, Inc.
Sources (1)
- FDA UDI e2cc5473-8dd1-4e55-a94e-18d6cea2f23d 37 fields · synced Jun 7, 2026