AL-40 Skin Removal Kit

$49.99
Quantity

Description

Device Description

The AL-40 Skin Removal Kit is a hand-held, rechargeable device intended to remove skin tags and warts utilizing the principle of heat cauterization. When the device applies heat to the growth, the heat will destroy the tissue, leading to the removal of the skin tag or wart.
The device contains a power unit with 12 adjustable levels of intensity and two sizes of probes. The power unit is used to generate high-frequency electric current to heat the probe, and the probe transfers the heat to the tissue of targeted area, making it burn, carbonize,and eventually fall off. lt is suitable to be used at home, for individuals aged 18 years and older.

Indications for Use

The AL-40 Skin Removal Kit is indicated for the OTC treatment of common warts, plantar warts and skin tags.

510(k) Number: K010715

Device Name: AL-40 Skin Removal Kit

Manufacturer: DDC TECHNOLOGIES, INC.

Device Name: AL-40 Skin Removal Kit
Classification Name: POWERED LASER SURGICAL INSTRUMENT
Product Code: GEX
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: DDC TECHNOLOGIES, INC.
Registered Establishment Number: 2438558
Premarket Submission Number: K010715
Owner/Operator: DDC TECHNOLOGIES, INC.
Owner/Operator Number: 9041276
Establishment Operations: Manufacturer; Remanufacturer