# K052688: Ellipse Flex PPT, Model 9ESF7255

- Pathway: 510(k) (Abbreviated)
- Applicant: Danish Dermatologic Development A/S
- Decided: Dec 12, 2005 after 75 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: 8 generations back to K910422 (1992). 60 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043255: Ellipse Light SPT, Danish Dermatologic Development A/S (2005) Summary page 3.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems, Lumenis, Ltd. (2003) Summary page 3.

## Most influential descendants
- 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
- K140670: Ellipse I2PL+/Ellipse Multiflex+ (2014), 6 descendants of its own

## Indications for use
The Intended Use for Ellipse Flex PPT is: Ellipse Flex PPTis 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 (including but not limited to diffuse redness, telangiectasias, port wine stains). * Treatment of inflammatory acne. The Indications for Use for Ellipse Flex PPT are: Application Treatment Variable Fitzoatrick Skin Tye 1 2 3 4 5 6 Hair Removal HR Applicator Hair (Thin, Normal, Thick) HR-S Applicator Hair Removal -air (Thin, Normal, Thick) , , .V V / HR-D Applicator Treatment of Benign Pigmented Lesions Pigmentation I Vessel Size / V V V ® ® and Benign Vascular Lesions Treatment of Telangiectasias Vessel size (Thin, medium, thick) v / / / ® ® Treatment of Port Wine Stains Color (Red, blue) V / V/ ® ® Treatment of Individual Pigmented Lesions Pigment Color '/ V V V V ® Treatment of Inflammatory Acne / / V/ ® ® Key: / Allowed; (9 Not Allowed

Source page: https://510kreport.com/device/K052688
Methodology: https://510kreport.com/methodology