# K032397: Dual Yellow Laser, Model Dual Yellow D10B

- Pathway: 510(k) (Traditional)
- Applicant: Norseld Pty., Ltd.
- Decided: May 27, 2004 after 297 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: 6 generations back to K904627 (1991). 52 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000811: Nlite System, SLS Model Number A00-1025, Sls Biophile, Ltd. (2000) Summary page 1.
- K020729: Nlite System,Model A00-1051, Icn Photonics, Ltd. (2002) Summary page 1.
- K013461: Nlite System,Model A00-1025, Icn Photonics, Ltd. (2002) Summary page 1.
- K014130: Nlite System, Icn Photonics, Ltd. (2002) Summary page 1.
- K021180: Candela Vbeam Pulsed Dye Laser System, Candela Corp. (2002) Summary page 1.
- K023899: Dual Yellow Laser, Model D10B, Norseld Pty., Ltd. (2003) Summary page 1.
- K013940: Laser System Yellowstar, Asclepion-Meditec AG (2002)
- K983020: Compact KTP Laser, Cosmos Medical Technology (1998) Summary page 1.
- K981447: Dio-Light 60 Laser System, Nidek, Inc. (1998) Summary page 1.
- K980201: Dio-Light Laser System, Nidek, Inc. (1998) Summary page 1.
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 1.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.
- K001784: Viridis Laser, Cosmos Medical Technology (2000)

## Most influential descendants
- K132976: Advatx (2014), 1 descendant of its own
- K250189: AdvaTx (2025), 0 descendants of its own

## Indications for use
The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angiorma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars, Striea, and Psoriasis. Podiatry - for benign cutaneous lesions and warts. The Dual Yellow lase, operating at 511 rm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous pigmented lesions including but not limited to: Lentigines, Solar keratoses, Adenoma serabaceumn, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringornas Seborrhoeic keratoses Verrucae vulgaris, and Warts.

Source page: https://510kreport.com/device/K032397
Methodology: https://510kreport.com/methodology