# K113588: Spectra Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Feb 22, 2012 after 79 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: 12 generations back to K910422 (1992). 128 ancestors in all.
82 later devices descend from it; 9 cite it directly.
0 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103455: Spectra Laser System, Lutronic Corporation (2011) Summary page 1.
- K061436: Palomar Q-Yag 5 ND:Yag Laser System, Palomar Medical Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K133254: Revlite Q-Switched ND:Yag Laser System (2014), 57 descendants of its own
- K143105: Picosure Workstation (2015), 49 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K160607: PicoWay Laser System (2016), 34 descendants of its own
- K162454: PicoWay Laser System (2017), 33 descendants of its own

## Indications for use
The SPECTRA Laser System in indicated for: the incision, excision, ablation, vaporization of soft tissues, for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm Wavelength (nominal delivered energy of 585 rim and 650 rim with optional dye handpieces): -Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) -Removal of Epidermal Pigmented Lesions -Removal of Minor Vascular Lesions including but not limited to telangiectasias -Treatment of Lentigines -Treatment of Cafd-Au-Lait -Treatment of Seborrheic Keratoses -Treatment of Post Inflammatory Hyper'Pigmentation -Treatment of Becker' s Nevi, Freckles and Nevi Spilus 1064nm Wavelength: -Tattoo removal: dark ink (black, blue and brown) -Removal of Nevus of Ota -Removal or lightening of unwanted hair with or without adjuvant preparation. -Treatment of Common Nevi -Skin resurfacing procedures for the treatment of acne scars and wrinkle -Treatment of melasma

Source page: https://510kreport.com/device/K113588
Methodology: https://510kreport.com/methodology