# K992482: Delight II Hair Removal System (the Delight System)

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy, Ltd.
- Decided: Dec 27, 1999 after 154 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: 2 generations back to K892514 (1990). 3 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963249: Epilight Hair Removal System, Esc Medical Systems, Ltd. (1997) Summary page 1.

## Most influential descendants
- K041554: Aip Intense Pulsed Light System (2005), 9 descendants of its own
- K062048: Aesthera Photopneumatic (PPX) System (2006), 4 descendants of its own
- K083730: Isolaz (2009), 3 descendants of its own
- K062589: Serenity PSF (Pneumatic Skin Flattening) System (2006), 3 descendants of its own
- K101415: Theraclear (2010), 1 descendant of its own

## Indications for use
The DeLightTM II HR System is intended for removal of unwanted body and/or facial hair in adults. The System is specifically indicated for dermatological use by physicians and healthcare professionals.

Source page: https://510kreport.com/device/K992482
Methodology: https://510kreport.com/methodology