Secret RF Smartcure

FDA UDI

Class II (US FDA UDI)

by Ilooda.co., Ltd

Identity

Trade Name: Secret RF Smartcure FDA UDI
Generic Name: Electrosurgical handpiece, single-use FDA UDI
Device Name: MTR 2.0 Smartcure FDA UDI
Model / Reference: MTR 2.0 Smartcure FDA UDI
Description: MTR 2.0 Smartcure FDA UDI

Identifiers

Primary DI / UDI-DI: 08800023201376 FDA UDI
510(k) Number: K182355 FDA UDI
FDA Product Code: GEI FDA UDI
OUH FDA UDI
GMDN Term: Electrosurgical handpiece, single-use 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical handpiece, single-use

Secret RF Smartcure by Ilooda.co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K182355 also covers:

Secret RF Smartcure Applicator With Electrodes — 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: Ilooda.co., Ltd

Sources (1)

FDA UDI 0b5426d3-4afd-4dd4-b933-3b19a3b9d9d9 35 fields · synced Jun 8, 2026