1NEED Pro

The 1NEED Pro is a rechargeable, handheld microneedling device with a sterile single-use cartridge containing 14 microneedles. It creates microscopic punctures in facial skin by means of reciprocating needles at adjustable depths (0–2.0 mm in 0.25 mm increments). The device is intended to improve the appearance of facial acne scars in adults aged 22 years or older through a standard three-treatment protocol spaced 4 weeks apart.

Both the 1NEED Pro and predicate device (Dr.pen K230420) share identical technological features: 14 radially arranged 34-gauge stainless steel needles, 6300–7700 RPM motor speed, 105–128 stamps/second puncture rate, 1.5 mm recommended penetration depth with 2.0 mm maximum, rechargeable Li-ion battery power, microprocessor control with embedded software, and sterile disposable cartridges with cross-contamination barriers. Both include identical needle geometry, spacing (2 mm), and the same three-treatment protocol.

Not stated in this summary.

The 1NEED Pro is substantially equivalent because it has identical intended use (treating acne scars), identical mode of action (mechanical microneedling), and identical technological characteristics including needle specifications, motor performance, penetration depths, and treatment protocol as the legally marketed predicate Dr.pen device. Nonclinical bench testing—including motor speed, penetration accuracy, needle bonding strength, cartridge life, and microbial ingress testing—demonstrated the device performs as safely and effectively as the predicate, meeting the same safety and effectiveness profile for the same indication in the same patient population.