# K083730: Isolaz

- Pathway: 510(k) (Special)
- Applicant: Aesthera Corporation
- Decided: Jan 9, 2009 after 24 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: 11 generations back to K910422 (1992). 81 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K062048: Aesthera Photopneumatic (PPX) System, Aesthera Corporation (2006) Summary page 1.

## Most influential descendants
- 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 IsolazTM System is designed to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild, to moderate inflammatory acne (acne vulgaris) in all-skin types (Fitzpatrick I-VI).

Source page: https://510kreport.com/device/K083730
Methodology: https://510kreport.com/methodology