SkinClear Q-Switched Nd:YAG Laser
by Global USA Distribution, LLC
510(k) K083272
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083272 | Date16 Dec 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SkinClear Q-Switched Nd:YAG Laser is a Q-switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser designed for dermatological applications. It emits a 1064 nm wavelength to target and remove dark ink tattoos, as well as pigmented lesions, through controlled laser energy delivery. The device operates by generating high-intensity, short-duration pulses to selectively break down chromophores in the skin without excessive thermal damage to surrounding tissues. Its precision makes it suitable for treating superficial and deeper pigmented areas, including tattoos and vascular lesions.
The SkinClear Q-Switched Nd:YAG Laser is supplied as a console-based system, including a power supply, electronic controls, cooling system, LCD display, handpiece, and footswitch. It is intended for use in clinical settings by trained professionals, such as dermatologists or plastic surgeons, and requires proper training in laser safety and operation. The device is classified under FDA 510(k) clearance (K083272) and is intended for single-use applications per session, though the console and handpiece may be reused with appropriate maintenance. No specific sterility or MRI safety information is provided in the regulatory data.
Other devices from Global USA Distribution, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the SkinClear Q-Switched Nd:YAG Laser used for?
The SkinClear Q-Switched Nd:YAG Laser is specifically designed for dermatological applications, targeting and removing dark ink tattoos and pigmented lesions. It achieves this through controlled delivery of high-intensity, short-duration pulses at a 1064 nm wavelength, which selectively break down chromophores in the skin without causing excessive thermal damage to surrounding tissues. This precision makes it effective for both superficial and deeper pigmented areas.
How is the SkinClear Q-Switched Nd:YAG Laser supplied and what components are included?
The SkinClear Q-Switched Nd:YAG Laser is supplied as a console-based system, including a power supply, electronic controls, cooling system, LCD display, handpiece, and footswitch. The console and handpiece are designed for reuse with proper maintenance, while the laser energy delivery components are intended for single-use per session.
Is the SkinClear Q-Switched Nd:YAG Laser sterile and how should it be stored?
The regulatory data does not specify sterility requirements for the SkinClear Q-Switched Nd:YAG Laser console or handpiece. However, since it is intended for clinical use by trained professionals, standard infection control protocols should be followed. The console and reusable components should be stored in a clean, dry environment, protected from dust and moisture, and maintained according to manufacturer guidelines to ensure proper functionality and safety.
Can the SkinClear Q-Switched Nd:YAG Laser be reused for multiple sessions?
The console and handpiece of the SkinClear Q-Switched Nd:YAG Laser are designed for reuse with appropriate maintenance. However, the specific components responsible for delivering laser energy are intended for single-use per session. Reuse of these components is not recommended unless explicitly stated by the manufacturer’s instructions for use.
Who is authorized to use the SkinClear Q-Switched Nd:YAG Laser, and what training is required?
The SkinClear Q-Switched Nd:YAG Laser is intended for use in clinical settings by trained professionals, such as dermatologists or plastic surgeons. Users must receive proper training in laser safety and operation to ensure safe and effective use. This includes understanding the device’s specifications, safety protocols, and adherence to manufacturer guidelines for handling and maintenance.