# K043255: Ellipse Light SPT

- Pathway: 510(k) (Traditional)
- Applicant: Danish Dermatologic Development A/S
- Decided: Feb 24, 2005 after 92 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: 7 generations back to K910422 (1992). 54 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems, Lumenis, Ltd. (2003) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 2.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 4.
- K984110: Laserscope Coolspot, Laserscope (1998) Summary page 4.

## Most influential descendants
- K052688: Ellipse Flex PPT, Model 9ESF7255 (2005), 23 descendants of its own
- K060516: Ellipse 12PL, Model 9ESL7228 (2006), 12 descendants of its own
- K112669: Tattoostar Effect Y (2012), 8 descendants of its own
- K081408: Ellipse Multiflex (2008), 7 descendants of its own
- K173692: D-Actor 200 Vibration Massage System (2018), 6 descendants of its own

## Indications for use
The Intended Use for Ellipse 12PL is: Ellipse 12 PL is intended for use in dermatology. * Hair removal (permanent hair reduction). * Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness).

Source page: https://510kreport.com/device/K043255
Methodology: https://510kreport.com/methodology