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

Cited in this 510(k)

Cited as predicate

Device details

FDA 510(k) registration fields

K number: K213250
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: 2021-09-30
Decision date: 2022-06-24
Submission type: Traditional
Technology type: Other(AI inferred)
Clinical applications: Skin resurfacingSurgical cutting
Primary application: Skin resurfacing
Classification source: AI classified

Indications for Use

The Secret Duo 1540 nm laser handpiece is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Intended Use

The Secret Duo 1540 nm laser handpiece is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Summary parsed at:2026-06-01 05:38:42 UTC

Predicate devices

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