ACTIVO

Daeju Meditech Engineering 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

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242206
Device name
ACTIVO
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-07-29
Decision date
2024-09-27
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cuttingPigment treatmentVascular treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm)
Tattoo Removal: Dark ink (blue and black) (1064 nm)
Tattoo Removal: light ink (red, sky blue, green) (532 nm)
telangiectasias (532 nm)
spider nevi (532 nm)
solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm)
nevus of ota (1064 nm)

Intended Use

Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm). Tattoo Removal: Dark ink (blue and black) (1064 nm), Tattoo Removal: light ink (red, sky blue, green) (532 nm), telangiectasias (532 nm), spider nevi (532 nm), solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm), nevus of ota (1064 nm).

Device Description

The ACTIVO is based on the Nd:YAG(1064nm) and KTP Nd:YAG(532nm) laser technology. It is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy(1064nm). This converted light energy pumps the Nd:YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light(532nm). As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

Summary parsed at:2026-06-01 05:29:14 UTC

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