# K021975: Lasersystem Beautystar 532

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion-Meditec AG
- Decided: Sep 13, 2002 after 88 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: 4 generations back to K933880 (1994). 14 ancestors in all.
24 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990174: Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV, Fisma, Inc. (1999) Summary page 1.
- K951034: Aura Laser System, Laserscope (1995) Summary page 2.
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 2.
- K002296: Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15, Ceram Optec, Inc. (2000) Summary page 2.
- K020071: Viridis Derma Laser, Quantel Medical (2002) Summary page 2.
- (no number) HGM Atlas-Elite, Model E-80: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K010885: Uni-Laser 470, Medart Corp. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K042496: Adept Ultralite 532 Laser (2004), 23 descendants of its own
- K063396: Velure Family of Diode Lasers and Delivery Device Accessories (2007), 22 descendants of its own
- K100143: Pilot Diode Laser, Model 002-00139 (2010), 20 descendants of its own
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own
- K102036: Doctor Surgery Diode Lasers Family (2010), 7 descendants of its own

## Indications for use
The BeautyStar 532 is intended for Vaporization and Photocoagulation of vascular and pigmented lesions in soft tissue. The laser system BeautyStar is restricted to sale to or use by licensed professionals in the United States.

Source page: https://510kreport.com/device/K021975
Methodology: https://510kreport.com/methodology