# K062048: Aesthera Photopneumatic (PPX) System

- Pathway: 510(k) (Traditional)
- Applicant: Aesthera Corporation
- Decided: Sep 7, 2006 after 49 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: 10 generations back to K910422 (1992). 80 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041554: Aip Intense Pulsed Light System, Aesthera Corporation (2005) Summary page 1.
- K051268: Radiance Acne System with Cleartouch Light Unit, Radiancy, Ltd. (2005)
- K052442: Radiancy Skinstation with Psoriasis Light Unit Assembly, Radiancy (Israel), Ltd. (2006) Summary page 1.
- K060411: Radiancy Cleartouch Lite Acne Clearance System, Radiancy (Israel), Ltd. (2006) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.
- K043319: Clareon and Solarus Pulsed Light Devices and Accessories, Novalis Medical, LLC (2004) Summary page 1.

## Most influential descendants
- K083730: Isolaz (2009), 3 descendants of its own
- K101415: Theraclear (2010), 1 descendant of its own
- K123889: Acleara, Theraclear (2013), 0 descendants of its own
- K121515: Isolaz 2 Intense Pulsed Light System (2012), 0 descendants of its own

## Indications for use
The Aesthera Photopneumatic TM (PPxTM) System is intended for: * The treatment of benign vascular and pigmented lesions; • Permanent hair reduction; * The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris). The Aesthera PhotopneumaticTM (PPXTM) System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Source page: https://510kreport.com/device/K062048
Methodology: https://510kreport.com/methodology