(50 days)
The device is intended for use in dermatologic and general surgical procedures.
The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal.
The indications for use for the handpiece of 1064nm include:
- -The Hair Removal 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.
- Treatment of Pseudo folliculitis Barbae (PFB) -
- Use on all skin types (Fitzpatrick I-VI), including tanned skin. -
The indications for use for the handpiece of 808 nm include:
- -The Hair Removal (HR) 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.
- The treatment of benign vascular and pigmented lesions. -
- -Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The indications for use for the handpiece of 755 nm include:
- The Hair Removal (HR) 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.
- The treatment of benign vascular and pigmented lesions. -
- -Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Quadruple Laser System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.
The Laser treatment device is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.
The proposed device includes power supply system, control system, control system, cooling system, laser system.
The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.
The Quadruple Laser System (Models: CPMT ARES, CPMT NEMESIS, CPMT NYX PLUS, CPMT GRACE PLUS) obtained 510(k) clearance (K222915) through demonstrating substantial equivalence to predicate devices (K211722 and K172193). The review was based on non-clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 for "Surface – intact skin" (contact |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.