# K102050: Q-Switched ND:Yag Laser System, Model Globalcure-SC6

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laser Co., Ltd.
- Decided: Jul 29, 2010 after 8 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: 1 generation back to K073436 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073436: Spectra Vrmii 1-Switched ND:Yag Laser System, Lutronic Corporation (2007) Summary page 2.

## Indications for use
The Q-Switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Café-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

Source page: https://510kreport.com/device/K102050
Methodology: https://510kreport.com/methodology