Manufacturer
Ilooda Co,., Ltd.Secret Duo
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
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
- 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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Cited as predicate
0No later 510(k)s cite this device yet
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