# K213250: Secret Duo

- Pathway: 510(k) (Traditional)
- Applicant: Ilooda Co,., Ltd.
- Decided: Jun 24, 2022 after 267 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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.

Source page: https://510kreport.com/device/K213250
Methodology: https://510kreport.com/methodology