Manufacturer
Finemec Co., Ltd.Noblex Long Pulse Alexandrite Laser
Country / Region:Korea, Republic of (KR)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
- K143666
- Device name
- Noblex Long Pulse Alexandrite Laser
- Company
- Finemec Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-12-23
- Decision date
- 2015-04-23
- Submission type
- Traditional
- Technology type
- Alexandrite(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Noblex Long Pulse Alexandrite Laser is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I -VI) including tanned skin. It is also indicated for the treatment of benign vascular lesions, benign pigmented lesions and wrinkles.
Intended Use
The Noblex Long Pulse Alexandrite Laser is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I -VI) including tanned skin. It is also indicated for the treatment of benign vascular lesions, benign pigmented lesions and wrinkles.
Device Description
The Nobelx Long Pulsed Laser system produces a pulsed beam of coherent near infrared (755nm) light. This beam is directed to the treatment zone by fiber optic coupled to hand-piece. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid highly localized temperature increase to the target chromospheres such as Hair removal and Pigment treatment. This increases localized temperature of the chromospheres to smaller particles. By directing the beam onto specific tissue locations, using different hand-pieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. 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. This equipment is composed of the main body and a hand-piece which is an irradiation device and as an accessory part, protective goggles for protection of the worker. Operation principle: This equipment is controlled by a micro processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board. Meanwhile, the control board connected to the touch screen is connected to the lamp of the hand-piece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.
Summary parsed at:2026-06-01 06:10:44 UTC
Predicate devices
2Cited as predicate
1Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
1 submission cite K143666 as a predicate
