EXCEED Unlimited*
Exceed Unlimited is a German-engineered medical microneedling device, FDA-cleared for facial wrinkles and facial acne scars.
- Dual FDA IndicationsFacial wrinkles and facial acne scars
- Safety MembraneBlocks fluid backflow into the handpiece
- Six-Needle Tilting PlateFollows the skin for perpendicular entry
- 900 Channels / SecondDense, even coverage at up to 150 Hz
*FDA-cleared for the improvement of facial wrinkles and facial acne scars in adults. Available to licensed healthcare professionals only.
Clinically Proven Improvement
Across Both FDA-Cleared Indications
Peer-reviewed studies confirmed significant improvement in facial wrinkles and
reduction in acne scarring with the six-needle tilting plate of the Exceed platform.
Introduction to Medical Microneedling
Microneedling creates controlled micro-channels in the epidermis and dermis. These micro-injuries prompt the body to release growth factors, driving fibroblast activity and the synthesis of new collagen and elastin just beneath the basal layer.
Exceed performs this with a six-needle tilting plate that adapts to the skin’s surface, allowing circular working technique and consistent perpendicular penetration — the difference between a medical-grade device and a cosmetic pen.
Collagen Induction Therapy (CIT)
Phase 1
Injury
Bleeding & Platelet Release
Neutrophils
Monocytes
Release of Growth Factors
- Epidermal Growth
- Fibroblast Chemotaxis
- Fibroblast Proliferation
- Matrix Production
Phase 2
Tissue Proliferation
Continued Release of Growth Factors from Fibroblasts, Keratinocytes & Monocytes
- Epidermal Growth
- Fibroblast Proliferation
- Collagen III, IV & I
- Elastin
- Proteoglycans
- GAGs
- Angiogenesis
Phase 3
Fibroplasia & Tissue Remodeling
Vascular Maturation
Collagen III
Collagen I
Skin Tightening
German Engineering for Clinical Precision
Stimulates
Collagen Induction
Controlled micro-channels trigger the skin’s natural regenerative response.
Adapts
Tilting Needle Plate
Follows skin contour for perpendicular entry and circular treatment technique.
Seals
Single Use Cartridge
Patented safety membrane prevents contamination of the handpiece between patients.
Proves
Published Evidence
Two peer-reviewed JCAD studies, on aging skin and acne scarring, underpin the wrinkle and acne scar clearances.
Tilting Six-Needle Plate Cartridge
Tilting Needle Plate
- Adapts to the skin surface
- Allows circular treatment with less drag
Sharpest Needles on the Market
- Safe needle penetration
- Medical-grade wounds
Patented Safety Membrane
- Prevents backflow and cross-contamination
Performance by Design
Precision, contour-adaptive contact and concentrated power, engineered so every pass delivers the same controlled result.
±0.15 mm
Depth precision
Documented depth accuracy supports consistent, protocol-based delivery, verified with high-speed camera testing in porcine skin.
90°
Perpendicular entry
The tilting plate follows facial contours so needles enter straight, allowing controlled circular technique with less drag.
150 Hz
Maximum frequency
Rapid cycling gives smoother gliding and dense, even coverage. In the acne-scar study the average treatment frequency was 147.2 Hz.
3.5×
Power per needle
Drive is concentrated across six needles for stable penetration with minimal skin displacement, compared with leading multi-needle pens.
Performance data published by the manufacturer. Power-per-needle comparison calculated as frequency × stroke ÷ number of needles.
Wound Profile Comparison
Traditional Pens
Fixed-plane design
EXCEED Unlimited
Tilting needle plate
Clinical Evidence
Exceed Unlimited holds FDA clearance K233709 for both indications. The clinical data behind it comes from two peer-reviewed studies on the Exceed platform, each using four treatments with blinded evaluation.
Image for illustrative purposes only. Courtesy of amiea med.
Facial Wrinkles
48 subjects, four treatments about 30 days apart. Three blinded evaluators graded each area at Day 150.
- Global wrinkle score improved by 1.23 grades and skin texture by 1.54 grades at Day 150
- No subject was graded as worsened in any of the three treated areas
Cleared for: adults 22+, Fitzpatrick I–III, in the glabellar, periorbital and cheek-fold areas.
Source: Ablon G. J Clin Aesthet Dermatol. 2018;11(8):29–34 · Read the study
Image for illustrative purposes only. Courtesy of Dr. Zoya Evsyukova, specialist in regenerative medicine and plastic surgeon.
Facial Acne Scars
Four treatments at four-week intervals, assessed three months after the final session.
- Overall scar severity improved by 0.91 grade; rolling scars responded most, at 1.06 grade
- Improvement was seen regardless of baseline scar severity
Cleared for: adults 22+, Fitzpatrick I–IV.
Source: von Dalwig-Nolda D, Ablon G. J Clin Aesthet Dermatol. 2020;13(8):17–22 · Read the study
Needle Cartridge Installation
EXCEED Unlimited Cartridge
Single-step insertion
- Screw down
SkinPen Cartridge
Triple-step insertion
- Line up the half-moon shape
- Push down the collar
- Rotate the collar while pushing
- Accidental locking
DermaPen 4 Cartridge
Digital insertion steps
- Pair and sync the device to a phone app
- Register the RFID cartridge via the app
- Line up the tip and screw down
Exceed vs Competitors
EXCEED Unlimited
FDA-cleared for
- Facial wrinkles
- Facial acne scars
Dermapen 4
FDA-cleared for
- Facial acne scars
SkinPen Precision Elite
FDA-cleared for
- Facial acne scars
- Neck wrinkles
The only device cleared for both facial wrinkles and facial acne scars.
- Facial wrinkles
- Facial acne scars
- Facial acne scars
- Facial acne scars
- Neck wrinkles
The only device cleared for both facial wrinkles and facial acne scars.
- Surgical-grade stainless steel
- Tilting plate adapts to contours
- Fine steel
- Not surgical-grade
- Surgical-grade stainless steel
Tilting plate minimizes epidermal trauma for extra comfort.
- Adjustable 100–150 Hz
- 3 speed settings
- Adjustable speed
- Fixed 115 Hz
3 speeds adapt to thicker or thinner tissue.
- Cordless
- 2 quick-change batteries
- 2 rechargeable batteries
- Power cord when batteries die
- Cordless
- Inductive charging
No charging cradle. Built for high-volume practices.
More power per needle: smoother entry, less trauma, better results.
Competitor specifications as published by NEOconcepts.
Treatment Protocol Overview
What a typical Exceed Unlimited course looks like for your patients. Always follow the instructions for use and the manufacturer's treatment protocols.
Before
Consultation & prep
The provider assesses the skin and sets a personalized plan. Topical numbing cream is applied 20–30 minutes before treatment.
During
The treatment
The handpiece glides across the skin creating thousands of controlled micro-channels. A typical session takes 30–60 minutes.
After
Recovery
Mild redness for 24–48 hours, similar to a light sunburn. Texture and radiance improve within 1–2 weeks.
Course
Results
Collagen remodeling continues over 3–6 months. The clinical studies used four sessions spaced about four weeks apart.
- 4 sessions in the clinical studies
- About 4 weeks apart
- Final assessment 2–3 months after the last session
Technical Specifications
- FDA clearance
- K233709 (2024) · improving the appearance of facial wrinkles and facial acne scars in adults
- Origin
- Engineered and manufactured in Germany · ISO 13485 quality management
- Needles
- 6 × 32-gauge surgical-grade stainless steel on a tilting plate
- Needle depth
- Adjustable, maximum 1.5 mm · documented precision ±0.15 mm
- Frequency
- Adjustable 100–150 Hz, three speed settings
- Channel rate
- Up to 900 microchannels per second
- Power
- Cordless · 2 rechargeable batteries · up to 10 hrs constant use · charging base
- Interface
- Digital screen with guided treatment protocols
- Cartridge
- Sterile, single-use · patented safety membrane · single-step screw-on installation
- Energy
- Mechanical only · no radiofrequency or heat delivered to the skin
Frequently asked questions
What is Exceed Unlimited?
Exceed Unlimited is a medical microneedling device engineered and manufactured in Germany. It creates controlled micro-channels in the epidermis and dermis to stimulate the body's own healing response, prompting the release of growth factors and the synthesis of new collagen and elastin.
What is Exceed Unlimited FDA-cleared for?
Exceed Unlimited is FDA-cleared for the improvement of facial wrinkles and facial acne scars in adults. It is the first and only microneedling system to hold FDA clearance for both indications.
Who can purchase and use Exceed Unlimited?
Exceed Unlimited is available to licensed healthcare professionals only. Order through TRU Biologix or contact our team for account setup.
What makes the six-needle tilting plate different?
The plate tilts to follow the contour of the skin, so every needle enters perpendicular with no drag or surface sag. This allows a circular working technique and consistent penetration. The cartridge uses six 32-gauge surgical-grade stainless steel needles.
What is the safety membrane?
Every Exceed cartridge contains a patented membrane inside the housing that blocks fluid from travelling back into the handpiece, preventing contamination between patients. Cartridges are single use — one per patient, disposed of after every treatment.
How fast is Exceed Unlimited?
Exceed Unlimited creates 900 microchannels per second, with an adjustable frequency of 100–150 Hz across three speed settings so the device can be adapted to thicker or thinner tissue.
How long does the battery last?
Exceed Unlimited is cordless and runs for up to 10 hours of constant use on two quick-change batteries. There is no charging cradle, which suits high-volume practices.
How is the cartridge installed?
Installation is a single step: line up the cartridge and screw it down.
Is there published clinical evidence?
Yes. Two peer-reviewed studies published in the Journal of Clinical and Aesthetic Dermatology (JCAD), one on signs of aging skin (2018) and one on acne scarring (2020), underpin the facial wrinkle and facial acne scar clearances, confirming significant improvement across both indications with the six-needle tilting plate.
When will patients see results?
Study endpoints for periorbital wrinkles were measured at 90 days. Collagen induction continues through three phases — injury and growth-factor release, tissue proliferation, then fibroplasia and remodelling — so improvement develops progressively over that period.
Exceed Unlimited is FDA-cleared for the improvement of facial wrinkles and facial acne scars in adults and is available to licensed healthcare professionals only.