Microneedling in Tampa, FL
Not all microneedling devices are FDA-cleared. At 4EvaGlow, we use a professional FDA-cleared microneedling pen that has been reviewed by the U.S. Food and Drug Administration for specific medical-aesthetic indications. This ensures a higher standard of safety, performance, and reliability compared to non-FDA-cleared microneedling pens commonly used in spas or sold online.
Number Of Sessions
3–6 treatments
Average Treatment Duration
45–75 minutes
Microneedling
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Microneedling of face $199
$600 (3 sessions)
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Microneedling of neck $149
$550 (3 sessions)
What Is FDA-Cleared Microneedling Approved For?
Our microneedling device is FDA-cleared for the following indications:
✔ Improvement of facial acne scars
✔ Improvement of facial wrinkles
✔ Improvement of abdominal scars
✔ For adults 22 years of age and older
FDA clearance means the device has been evaluated for safety and effectiveness for these exact uses. These indications are regulatory-cleared, not cosmetic marketing claims.
FDA-Cleared Microneedling vs Non-FDA-Cleared Pens
Why this matters: Microneedling creates controlled micro-injuries in the skin. Devices without FDA clearance may not meet the safety and performance standards required for treating scars and wrinkles.
FDA-Cleared Microneedling Devices
Class II medical devices
Cleared by the FDA for acne scars and wrinkle improvement
Designed for professional clinical use
Controlled, consistent needle penetration
Higher safety and manufacturing standards
Backed by regulatory review and documentation
Non-FDA-Cleared Microneedling Pens
No FDA clearance for scar or wrinkle treatment
Often marketed for “skin rejuvenation” without cleared indications
Inconsistent needle depth and motor performance
Variable results and increased treatment risk
No regulatory validation for treatment claims
Treatment Benefits
- Improved Skin Texture: Microneedling can reduce the appearance of fine lines, wrinkles, and acne scars, resulting in smoother skin.
- Increased Collagen Production: Moreover, it stimulates collagen and elastin, resulting in firmer, more elastic skin.
- Reduced Pore Size: As a result, it helps minimize the appearance of enlarged pores, leaving you with a more refined complexion.
- Enhanced Absorption of Skincare Products: Because it creates micro-channels in the skin, microneedling allows for deeper absorption of skincare products, thereby maximizing their effectiveness.
- Treats Hyperpigmentation: In addition, microneedling encourages cell turnover, which helps fade dark spots and even out skin tone.
- Minimal Downtime: Unlike more invasive procedures, microneedling typically involves minimal downtime. Although some redness and mild swelling may occur, most clients resume daily activities within 24-48 hours.
- Suitable for All Skin Types: Importantly, microneedling is safe and effective for all skin types and tones.
- Versatile Treatment Areas: Furthermore, microneedling can be performed on the face, neck, chest, hands, and other body areas that need rejuvenation.
- Non-Surgical & Low Risk: Finally, as a non-surgical procedure, microneedling carries minimal risk of side effects when performed by a qualified professional.
Why FDA Clearance Improves Microneedling Results
Choosing an FDA-cleared microneedling device provides:
More predictable and controlled treatment depth
Reduced risk of uneven skin trauma
Better outcomes for acne scars and fine lines
Technology validated for its intended clinical use
This is especially important when treating moderate to severe acne scarring, where precision directly impacts results.
Our FDA-First Approach at 4EvaGlow
At 4EvaGlow, we prioritize evidence-based aesthetic treatments. Every microneedling service is performed using FDA-cleared technology selected for safety, consistency, and performance—not trend-driven or unregulated devices.
Microneedling FAQ's
What is FDA-cleared microneedling?
FDA-cleared microneedling uses a device that has been reviewed by the U.S. Food and Drug Administration and cleared for specific indications, including improving acne scars and wrinkles. This means the device has met regulatory standards for safety and performance.
What indications is FDA-cleared microneedling cleared for?
FDA-cleared microneedling devices are cleared to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars in adults aged 22 years and older.
Is FDA-cleared microneedling better than non-FDA-cleared pens?
Yes. FDA-cleared microneedling devices have undergone regulatory review for specific uses, while non-FDA-cleared pens have not been evaluated by the FDA for treating acne scars or wrinkles.
Are non-FDA-cleared microneedling pens safe?
Non-FDA-cleared pens are not necessarily unsafe, but they have not been reviewed by the FDA for safety or effectiveness for treating scars or wrinkles. Their treatment claims may not be clinically validated.
Why does FDA clearance matter for microneedling results?
FDA clearance helps ensure consistent needle depth, controlled skin penetration, and reliable performance—factors that directly affect treatment safety and outcomes, especially for acne scars and fine lines.
Who is a good candidate for FDA-cleared microneedling?
Adults 22 years and older with acne scars, fine lines, uneven skin texture, or dull skin may benefit from FDA-cleared microneedling. A consultation is recommended to determine suitability.
How many FDA-cleared microneedling treatments are needed?
Most clients see improvement after one session, but optimal results for acne scars and wrinkles typically require a series of treatments spaced several weeks apart.