ACCENTO / HWA Dual/Single laser

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

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Device details

FDA 510(k) registration fields

K number
K160227
Device name
ACCENTO / HWA Dual/Single laser
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-01-29
Decision date
2016-04-22
Submission type
Traditional
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removalPigment treatmentVascular treatmentSkin tightening
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The ACCENTO combined laser system is indicated for the following:

755 nm Long pulsed Alexandrite laser:
- Temporary hair reduction
- Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
- Treatment of benign pigmented lesions.
- Treatment of wrinkles.
- The photocoagulation of dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias).

1064nm Long pulsed Nd:YAG laser:
- The removal of unwanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin.
- Treatment of photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins.
- Coagulation and hemostasis of soft tissue.
- Benign pigmented lesions such as lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoo reduction (dark color) and plaques.
- Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar.
- Treatment of wrinkles.

Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Intended Use

The ACCENTO combined laser system is indicated for the following: 755 nm Long pulsed Alexandrite laser Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias) 1064nm Long pulsed Nd:YAG laser the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle.

Device Description

The ACCENTO Dual device are contained two separate laser heads 755nm long pulsed Alexandrite and 1065nm Nd: YAG laser. The output of each laser head is optically combined on the laser rail to delivery same beams path. This single delivery system can obtain either 755nm or 1064nm wavelengths. The LED touch screen equipped in Control panel to adjust parameters easily. Each laser heads has self contained circulation water system to cool system and laser head fully using distilled water at a controlled temperature. The ACCENTO laser system delivers laser energy with various pulse durations from 0.2ms to 350ms. The output of this laser is delivered to the area of treatment by means of lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch( Finger or Foots pedal) is used to control the delivery of laser pulse. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be deliver repetitively as long as the switch is depressed at repetition rates up to 10 pulses per second depending on the chosen pulse duration Energy from the laser is directed to the target area via optical fiber handpiece. The Dynamic Cooling system provides a short burst of Cryogen spray prior to firing the laser pulse, The Energy is delivered via optical fiber to handpiece with a spot size 2, 3, 5, 8,10,12,18, 20mm diameter circular beam on the skin. Operator may select parameters as desired fluence and repetition rate, and operated using touch screen and display panel. This device consist of Power supply and modulator system Optical laser Hand pieces and delivery system Circulator system Software control system, Dynamic cooling system, LED control panel. ACCENTO single device are contained 750nm Alexandrite laser only, and provided it optionally to treat related indication. This device also equipped with safety interlock systems to protect patients and user.

Summary parsed at:2026-06-01 06:05:46 UTC

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