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Secret Duo

Ilooda Co,., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Ilooda Co,., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K202043
Device name
Secret Duo
Company
Ilooda Co,., Ltd.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-07-23
Decision date
2021-04-23
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Secret Duo RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Intended Use

Secret Duo RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Summary parsed at:2026-06-01 05:41:26 UTC

Predicate devices

0

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Cited as predicate

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