Manufacturer
Daeju Meditech Engineering Co., Ltd.ACTIVO
Daeju Meditech Engineering Co., Ltd.
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
Predicate devices
1Helios III
K242206 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242206 as a predicate
