# K041554: Aip Intense Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Aesthera Corporation
- Decided: Apr 27, 2005 after 321 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 K910422 (1992). 27 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K033181: SPR System, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002) Summary page 1.
- K992482: Delight II Hair Removal System (the Delight System), Radiancy, Ltd. (1999) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K010618: Palomar Dermalux Pulsed Light System, Palomar (2001) Summary page 1.
- K003886: Palomar Spalight Pulsed Light System, Palomar Medical Technologies, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K020943: Sterile Disposable Vinyl Exam Gloves, Powder Free, Shanghai Antares Industries, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K071469: Inolase Serenity PSF ( Pneumatic Skin Flattening) System (2007), 1 descendant of its own

## Indications for use
The AlP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction. The AlP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Source page: https://510kreport.com/device/K041554
Methodology: https://510kreport.com/methodology