Manufacturer
Smedtrum Medical Technology Co., Ltd.Diode Laser System
Smedtrum Medical Technology Co., Ltd.
Country / Region:Taiwan (TW)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K230580
- Device name
- Diode Laser System
- Country / Region
- Taiwan(TW)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-03-02
- Decision date
- 2023-05-26
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size: Single-Wavelength Handpiece 810nm wavelength The 810nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a 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 regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes) Trio-Wavelength Handpiece The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR). The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Titanium diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: Benign vascular and vascular dependent lesions. 810nm Applicator Soprano Titanium 810 nm applicator intended use and indications for use: The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include: ⚫ The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a 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 regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) 755nm Applicator Soprano Titanium 755 nm applicator intended use and indications for use: The indications for use for the 755nm Diode Laser Module include: ⚫ The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a 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 regimen. ⚫ Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes) NIR Applicator NIR Applicator intended use and indications for use: The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.
Intended Use
The Diode Laser System includes 2 types of handpieces with same 1.2 x 1.4 cm spot size: Single-Wavelength Handpiece 810 nm wavelength The 810 nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a 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 regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes) Trio-Wavelength Handpiece The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).
Device Description
Diode Laser System is a photothermal effect surgical laser device intended for prescription use and is comprised mainly of three components: console, handpieces and water-loop cooling system. The laser wavelengths that ST-803 Diode Laser System uses can be well absorbed by melanin, which causes a rapid increase in temperature, destroying surrounding hair follicles, and finally removing hair. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The system can automatically identify different handpieces. The product includes 2 types of handpieces that are in the same spot size and 2 combinations of wavelengths. The diode is exited to emit a high-power therapeutic laser beam intended to reduce unwanted body hair (e.g., armpit, leg, arm, back, chest and bikini line). It is intended to be used by a trained professional to emit a laser of wavelength around 810 nm or 755+810+1064 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat.
Summary parsed at:2026-06-01 05:32:46 UTC
Predicate devices
1The Alma Soprano Titanium
K230580 references 1 predicate/reference device
Cited as predicate
1Picosecond Nd:YAG Laser System
1 submission cite K230580 as a predicate
