# K984424: Aura Dye Laser System (Adls)

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Mar 5, 1999 after 84 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.
137 later devices descend from it; 1 cites it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laserscope Aura laser system: named in the summary without a submission number
- (no number) Laserscope Orion laser system: named in the summary without a submission number
- (no number) Coherent Versa Pulse C laser system: named in the summary without a submission number
- (no number) Candela ScleroPulse laser system: named in the summary without a submission number
- (no number) Cynosure PhotoGenica LV laser system: named in the summary without a submission number

## Most influential descendants
- K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B (2005), 136 descendants of its own
- K050673: Candela Family of Pulse Dye Laser Systems (2005), 133 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own

## Indications for use
The Laserscope Aura Dye Laser System and Accessories are intended for the surgical Incislonvexcision, vaparization, ablation and coagulation of sott tissue. “All soft tissue is Included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, musdle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dermatology/Plastic Surgery:indications include epidermal nevi, telangiectasia, spidé} veins, verrucae, skin tags, anal tags, keratoses, debulking benign tumors and cysts, superficial skin lesions, and benign pigmented lesions. General Surgery: Indications include surgical incision/excision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of extemal tumors and lesions, complete or partial resection of intemmal organs, tumors and lesions, tissue ablations andfor vessel coagulation may. be indicated. Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminata, giant perineal condyloma and verruccous carcinoma), vulvar tasions, polyps and familia! polyps of the colon. Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma. OralMaxillofacial:Indications include benign oral tumocs, oral and glossal lesions. Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, excision of carcinogenic tissue and oral leukoplakia. Ophthalmology: Indications include soft tissue surrounding the eye and orbit.. Podiatry: Indications include wart, plantar verrucae, and farge mosiac verrucae.

Source page: https://510kreport.com/device/K984424
Methodology: https://510kreport.com/methodology