# K024206: Aura Isurgical Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Nov 17, 2003 after 332 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.
198 later devices descend from it; 3 cite it directly.
0 of 199 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) ClearLight Phototherapy System Model C420: named in the summary without a submission number
- (no number) Laserscope Lyra Laser System and Accessories: named in the summary without a submission number
- (no number) Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices and Accessories: 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 i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.

Source page: https://510kreport.com/device/K024206
Methodology: https://510kreport.com/methodology