Identity
- Trade Name
- QUADESSY Set Package FDA UDI
- Generic Name
- Intradermal radio-frequency ablation system FDA UDI
- Model / Reference
- QD1-M400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016905045 FDA UDI
- 510(k) Number
- K241157 FDA UDI
- FDA Product Code
- OUH FDA UDIPBX FDA UDIGEI FDA UDI
- GMDN Term
- Intradermal radio-frequency ablation 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Intradermal radio-frequency ablation system
QUADESSY Set Package by CLASSYS Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K241157 also covers:
- MTR-AC-01 — CLASSYS Inc.
- MTR-AC-04 — CLASSYS Inc.
- MTR-AC-27G — CLASSYS Inc.
- Max-25 — CLASSYS Inc.
- Max-25C — CLASSYS Inc.
- Max-64C — CLASSYS Inc.
- Max-M25 — CLASSYS Inc.
- Max-M25C — CLASSYS Inc.
- QUADESSY Deeplus hand piece — CLASSYS Inc.
- QUADESSY Main Unit — CLASSYS Inc.
- QUADESSY Neutral hand piece — CLASSYS Inc.
- QUADESSY Smartcure(Basic) hand piece — CLASSYS 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
- CLASSYS Inc.
Sources (1)
- FDA UDI 8bf9ab64-f5ce-4e19-b1bb-f026e7307d24 33 fields · synced May 30, 2026