# K083915: Angelite Family of Intense Pulsed Light Systems, Models Angelite-DDC and Angelite-SDC

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laser Co., Ltd.
- Decided: Jan 29, 2009 after 30 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own
- K220794: 10PL (2022), 0 descendants of its own
- K101901: Ipl Therapy System (2011), 0 descendants of its own

## Indications for use
The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow: 1. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of inflammatory acne. 2. Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of benign (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of civatte; leg veins, facial veins and venous malformations. 3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal).

Source page: https://510kreport.com/device/K083915
Methodology: https://510kreport.com/methodology