# K112669: Tattoostar Effect Y

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: May 11, 2012 after 240 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: 13 generations back to K943450 (1995). 190 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071451: Tattoostar Y, Asclepion Laser Technologies GmbH (2007) Summary page 1.
- K103455: Spectra Laser System, Lutronic Corporation (2011) Summary page 1.
- K081541: Dermablate Effect, Asclepion Laser Technologies GmbH (2009) Summary page 1.
- K051214: Aluma Skin Renewal System, Lumenis, Inc. (2005) Summary page 1.
- K052688: Ellipse Flex PPT, Model 9ESF7255, Danish Dermatologic Development A/S (2005) Summary page 1.

## Most influential descendants
- K173692: D-Actor 200 Vibration Massage System (2018), 6 descendants of its own
- K210451: OrthoGold 100 (2021), 2 descendants of its own
- K220538: DolorClast Radial (2022), 1 descendant of its own
- K243488: Vmat Pro (2025), 0 descendants of its own
- K221865: BTL-094 (2023), 0 descendants of its own

## Indications for use
The TattooStar Effect Y laser is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and unwanted hair and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows: 1064 nm:. Removal of black and blue tattoo color Removal of unwanted hair Skin resurfacing 532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented burn and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafo au-lait spots) Removal of red tattoo color Removal of minor vascular lesions 585 nm: Removal of sky blue tattoo color The Asciepion Pulsed Light of the TattooStar Effect Y is intended for permanent hair reduction, treatment of vascular lesions, pigmented lesions and inflammatory acne. Depending on the different filters, the indications are as follows: 400 -750 nm: Acne 500 - 1200 nm: Hair removal of blond hair, skin type 1-11 Vascular lesions, skin type 1-11 550 -1200 nm: Hair removal of brown and black hair, skin type 1-11 Hair removal of blond, brown and black hair, skin type Ill Vascular lesions, skin type II-IV Pigmented lesions, skin type I-IV 650 - 1200 nm: Hair removal of black hair, skin type IV The Radiofrequency is intended for dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. The Acoustic Wave is intended for the activation of connective tissue.

Source page: https://510kreport.com/device/K112669
Methodology: https://510kreport.com/methodology