# K133319: ET Lightsheer 1060, High Speed Lightsheer 1060

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Mar 20, 2014 after 143 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: 10 generations back to K910422 (1992). 104 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 2.
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 3.
- K112715: Candela Gentlemax Family of Lasers, Candela Corp. (2011) Summary page 2.

## Most influential descendants
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (2017), 14 descendants of its own
- K141555: Advantage (2014), 14 descendants of its own
- K180719: InMode Diolaze System (2018), 13 descendants of its own
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K192483: MeDioStar (2020), 3 descendants of its own

## Indications for use
ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas. lelangiectasia, part wine stains, leg veins and other benign vascular lesions. ET LightSheeir 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbee (PFB ). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. ET LightSheer 1060 and High Speed LightSheer 1060 are intended for the treatment of benign pigmcnted lesions, including age spots, solar lentigines, cafd-au-lait spots, nevi of OteA/to, melasma, Becker's nevi and other benign pigmented lesions. ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles. ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K133319
Methodology: https://510kreport.com/methodology