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Methods and devices

Microneedling methods and devices

Every method punctures the skin with fine needles. They differ in how the needles move and whether they carry heat.

By method

From hand rollers to RF microneedling

1997 · A. Camirand

Needle dermabrasion

Device. Tattoo machine without pigment

A tattoo machine run without ink punctures a scar many times. Camirand used it on pale, raised and unsightly scars after surgery.[1][2]

Suits. Pale (achromic) and hypertrophic scars.

Trade-offs. One small series with no controls. The paper reported no complications.

2006 · D. Fernandes; Liebl

Dermaroller

Device. Hand-rolled drum, 0.5-3 mm needles

A 2 x 2 cm drum holds 192 needles in 8 rows, 0.5 to 3 mm long and 0.1 to 0.25 mm wide. Derma-stamps carry 0.2 to 3 mm needles pressed straight down on single scars. Aust and Fernandes reported 480 patients treated with a roller in South Africa and Germany.[1][2][3]

Suits. Acne scars, fine wrinkles, lax skin and stretch marks. Stamps suit single scars such as chickenpox scars.

Trade-offs. Depth depends on how hard the roller is pressed. Most patients in the 480-patient series had one treatment; some had up to four.

2018 · Bellus Medical (SkinPen)

Motorized microneedling pen

Device. Motorized pen, 0.25-1.5 mm on the face

A motor drives disposable needle cartridges in and out of the skin. SkinPen sets 11 depths from 0 to 2.5 mm and runs at 7,000 RPM. In March 2018 it was authorized through De Novo DEN160029, which created the FDA microneedling device classification.[1][2][3]

Suits. Facial acne scars in adults 22 and older, the authorized use. Pen tips reach narrow areas such as the nose, eyes and lips.

Trade-offs. Safety and effectiveness above 1.5 mm were not evaluated. In its trial, 11 of 20 people (55%) improved on the scar scale at 6 months.

2016 · M. Asif, S. Kanodia, K. Singh

Microneedling with PRP

Device. Mechanical needling plus the patient's platelets

Blood is drawn and spun to concentrate platelets, which are applied or injected after needling. In a 50-patient split-face study, the PRP side improved 62.2% against 45.8% for needling with distilled water.[1][2][3]

Suits. Atrophic acne scars. A meta-analysis of 14 studies (472 patients) found PRP raised the odds of more than 50% improvement (odds ratio 2.97).

Trade-offs. Microneedling devices are not FDA-approved to deliver PRP. An HIV cluster in New Mexico was traced to PRP microneedling facials at an unlicensed spa.

2009 · B.M. Hantash

Bipolar fractional RF microneedling

Device. Needle electrodes heat the reticular dermis

Five pairs of microneedle electrodes deliver RF energy into the dermis with real-time temperature control at 60 to 80 degrees C. In a 100-subject multicenter trial, wrinkles improved 25.6% and laxity 24.1% at 6 months.[1][2][3]

Suits. Face and neck wrinkles and laxity, and acne scars. In 30 patients, acne scars and large pores improved in more than 70%. A review of 16 studies (481 patients) found it likely effective for acne scars on its own.

Trade-offs. Erythema, swelling and bruising lasted 1 to 5 days. Two subjects had temporary pinpoint depressions. A meta-analysis of randomized trials found no significant scar benefit for RF microneedling over comparison treatments.

2013 · Lutronic

Infini

Device. RF microneedling

The Infini Radiofrequency System was cleared through 510(k) K121481 on June 25, 2013, as an electrosurgical cutting and coagulation device.[1][2]

Suits. The public database entry lists the device class, not the indication.

Trade-offs. The FDA has reports of burns, scarring, fat loss and nerve damage with RF microneedling devices as a class.

2016 · Sung Hwan E&B; ShenB

Vivace

Device. 36 needles, 0.5-3.5 mm

A disposable cartridge of 36 needle electrodes in a 6 x 6 array, adjustable from 0.5 to 3.5 mm in 0.1 mm steps. Cleared in January 2016 with an indication that includes percutaneous treatment of facial wrinkles in skin types I to V.[1][2]

Suits. Facial wrinkles in skin types I to V. In the 510(k) study, 17 of 28 (60.7%) improved by 1 point at 90 days.

Trade-offs. Erythema in 77% and edema in up to 19% of subjects, resolved within 24 hours. The 2021 clearance limits the wrinkle indication to the 1 MHz setting.

2018 · Lutronic

Genius

Device. 49 needles, 0.5-3.5 mm

A 7 x 7 bipolar microneedle array with depth adjustable from 0.5 to 3.5 mm. The user sets needle depth, power and duration. Cleared through 510(k) K180945 on December 10, 2018.[1][2][3]

Suits. Cleared indication: electrocoagulation and hemostasis in dermatologic and general surgical procedures.

Trade-offs. Heat forms around the uninsulated part of each needle. The FDA has reports of burns, scarring, fat loss and nerve damage with RF microneedling devices.

2019 · InMode

Morpheus8

Device. 24 pins, up to 4 mm

Fractional RF delivered through an array of multi-electrode pins. The Morpheus8 (Fractora) applicator has 24 pins and a 4.0 mm depth. Cleared through 510(k) K192695 on December 27, 2019.[1][2][3]

Suits. Cleared indication: electrocoagulation and hemostasis. Published facial uses include laxity, acne and acne scars.

Trade-offs. Among RF microneedling reports to the FDA from 2013 to 2025, the most frequent problems were texture changes (25%), pigment changes (18%) and fat loss (12%).

2020 · Jeisys Medical

Potenza

Device. RF microneedling, up to 4 mm

Delivers bipolar RF energy through microneedle electrodes, with six electrode tips for the motor handpiece. Depth reaches up to 4.0 mm. Cleared through 510(k) K192545 on February 20, 2020.[1][2][3]

Suits. Cleared indication: electrocoagulation and hemostasis in dermatologic and general surgical procedures.

Trade-offs. The FDA has reports of burns, scarring, fat loss and nerve damage with RF microneedling devices.