Lucid Q-PTP / HWA 55

Bison Medical Co, Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

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1

Cited as predicate

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Device details

FDA 510(k) registration fields

K number
K161670
Device name
Lucid Q-PTP / HWA 55
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-06-16
Decision date
2016-11-02
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cuttingPigment treatment
Primary application
Surgical cutting
Classification source
AI classified

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, Telangiectasias
- Treatment of Lentigines, Cafe-Au-Lait, Seborrheic 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, wrinkles

Intended 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

Device Description

The LUCID Q-PTP Q-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and optional 2 dye Handpieces are available that convert the 532nm wave length to 585nm and 650nm, using different Handpiece able to control various treatment fluence. This device is non-contacted mode and consists of main function, laser tube: placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator: amplifies the beam, through the Xe-gas contained lamp lamp: Xe-gas contains high pressure lamp to increase specific laser beam This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit. This system also consist of Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch.

Summary parsed at:2026-06-01 06:06:36 UTC

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