# K200110: SANDRO Dual

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Mar 16, 2020 after 59 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
Longest line of descent: 12 generations back to K910422 (1992). 139 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140122: Candela Gentlemax Family of Laser System, Candela Corp. (2014) Summary page 6.

## Most influential descendants
- K253828: Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) (2026), 0 descendants of its own
- K252877: SANDRO Dual (2025), 0 descendants of its own

## Indications for use
The SANDRO Dual Laser System is indicated for the following at the specified wavelength: 755nm Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias) 1064nm Removal of unwanted hair, for stable long term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick [-VI including tanned skin. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Source page: https://510kreport.com/device/K200110
Methodology: https://510kreport.com/methodology