# K103455: Spectra Laser System

- Pathway: 510(k) (Special)
- Applicant: Lutronic Corporation
- Decided: Apr 28, 2011 after 156 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: 11 generations back to K910422 (1992). 126 ancestors in all.
92 later devices descend from it; 2 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080248: Spectra Vrmiii Q-Switched ND: Yag Laser System and Dye Handpieces, Lutronic Corporation (2008) Summary page 1.
- K083889: Fotona QX ND:Yag/KTP Laser System Family, Fotona D.D. (2009)

## Most influential descendants
- K113588: Spectra Laser System (2012), 82 descendants of its own
- 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

## 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 nm and 650 nm 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 Caf6-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

Source page: https://510kreport.com/device/K103455
Methodology: https://510kreport.com/methodology