# K161670: Lucid Q-PTP / HWA 55

- Pathway: 510(k) (Traditional)
- Applicant: Bison Medical Co, Ltd.
- Decided: Nov 2, 2016 after 139 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 K910422 (1992). 129 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 4.

## Most influential descendants
- K241527: Pastelle Pro (2025), 3 descendants of its own
- K253344: Bellus-Q (2025), 0 descendants of its own
- K251464: TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (2025), 0 descendants of its own
- K250165: Pastelle (2025), 0 descendants of its own

## Indications for use
The LUCID Q-PTP Nd : YAG Laser System is 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 hand pieces): Tattoo removal light ink (red, tan, purple, orange, sky blue, green), Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Post Inflammatory Hyper-Pigmentation, Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: Tattoo removal: dark ink ( black, blue, brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle

Source page: https://510kreport.com/device/K161670
Methodology: https://510kreport.com/methodology