Manufacturer
Daeju Meditech Engineering Co., Ltd.NOABLE LASER
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
- K242207
- Device name
- NOABLE LASER
- 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
- 2025-03-07
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingAcne treatmentSkin resurfacingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia
Intended Use
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia.
Device Description
NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser, and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand-piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
Summary parsed at:2026-06-01 05:21:13 UTC
Predicate devices
2—
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Not ingested
A-FIT
K242207 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242207 as a predicate
