Identity
- Trade Name
- AcuTron Handpiece FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Model / Reference
- MOR-C1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016904765 FDA UDI
- 510(k) Number
- K211000 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical systemIntradermal radio-frequency ablation system
AcuTron Handpiece by CLASSYS Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intradermal radio-frequency ablation system.
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Cleared under the same submission
K211000 also covers:
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
- CLASSYS Inc.
Sources (1)
- FDA UDI 531fd24c-3f81-4da4-9802-25127dae3b8e 33 fields · synced May 30, 2026