# K131757: Tattoostar Effect Combo

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Jul 17, 2014 after 395 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: 14 generations back to K943450 (1995). 192 ancestors in all.
No later device cites it as a predicate yet.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112669: Tattoostar Effect Y, Asclepion Laser Technologies GmbH (2012) Summary page 1.
- K060787: Tattoostar Family, Asclepion Laser Technologies GmbH (2006) Summary page 1.

## Indications for use
The TattooStar Effect Combo is indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions, vascular lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows: 1064 nm: Removal of black and blue tattoo color 3-3.5 J/cmA2, 2-4 mm, 1-10Hz, 8 ns Skin resurfacing 1.5-2.5 J/cnr2, 5.5 mm, 10 Hz, 0.3 ms 1.5 J/cmA2, 7 mm, 2-5 Hz, 8 ns 532 rn: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented bum and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafe-au-Iait spots) 2-2.5 J/CMA 2 4mm, 1-5H-1, 8 ns Removal of red tattoo color 2 J/cmA2, 4mm, I-5Hz, Sns 585 nm: Removal of sky blue tattoo color 2-3 J/CMA 2, 2.5mm, I-5Hz, 8 ns 694nm: Removal of pigmented lesions 3 J/cmA2, 4-5.5 mm, 0.5-2 Hz, 40 ns Removal of black, blue and green tattoo color 2-3 J/cmA2, 4-5.5 mm, 0.5-2 Hz, 40 ns

Source page: https://510kreport.com/device/K131757
Methodology: https://510kreport.com/methodology