Manufacturer
Bison Medical Co, Ltd.RUBY STAR
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
- K150997
- Device name
- RUBY STAR
- Company
- Bison Medical Co, Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-04-15
- Decision date
- 2015-12-22
- Submission type
- Traditional
- Technology type
- Ruby(AI inferred)
- Clinical applications
- Surgical cuttingPigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
RUBY STAR Laser Q-switched 694nm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
Intended Use
RUBY STAR Laser Q-switched 694nm Ruby laser system is indicated for cutting, vaporization, and ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.
Device Description
RUBY STAR Q-switched laser system emits a beam of coherent light at 694nm with 25-30ns Pulse width, and 0.1 - 200j/cm2 Energy fluence via 7-Articulated arm. It consists of an articulated arm delivery system terminated in a hand piece, electronic power supply and interface circuitry, optical chamber with laser rod and cavity optics with cooling system, and an LCD color touch screen with foot pedal switch. Laser energy produced is delivered to the tissue by means of an articulated arm. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using a foot switch.
Summary parsed at:2026-06-01 06:11:06 UTC
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Cited as predicate
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