Agnes Medical Agnes RF

RF Microneedling · Precision single/tri-needle RF (eyes, acne)

CurrentFDA status under reviewBe the first to review

What it's actually cleared for: Verified: K203013 cleared AGNES for dermatological and general surgical procedures for electrocoagulation and hemostasis — eye bags and acne-gland work are off-label uses of that clearance; more recent filings (K243713, K250217) exist and are worth reviewing for current labeling.

Last verified: August 6, 2026 · How we verify

New: $30k–$50k|Used: $15k–$25kmarket estimate, no email required

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Bottom line

Not another all-purpose RF microneedling wand — a precision electrocoagulation tool built around partially insulated single and multi-needle tips that selectively destroy targets nothing else reaches non-surgically: under-eye fat pockets, sebaceous glands in recurring acne, syringomas, jowl fat. That focus is its moat and its ceiling: a specialist's device supporting premium niche pricing (eye bags at $2,000+ without a blepharoplasty) but not a general rejuvenation anchor. Verified FDA clearances and a growing US footprint make it more legitimate than its niche status suggests. Buy it as a differentiator, not a workhorse.

Overview

Niche precision device for eye bags/acne glands

How it works

The science

Focused RF through 9 specialized micro-insulated needle tips; insulation along the shaft confines thermal injury to the tip, allowing coagulation of a precise target — periorbital fat (eye bags), the sebaceous gland at the base of an acne pore, syringomas, small fat pads (jowls, double chin) — while sparing epidermis and surrounding dermis. For acne: destroying the gland aims at permanent elimination of the recurring lesion. For eye bags: coagulated fat is metabolized over 8-12 weeks with concurrent tightening. Local/topical anesthesia, a few days of swelling.

Patented tech

The micro-insulated needle system itself — variable insulation lengths and gauges per tip matched to target depth, plus impedance-controlled RF dosing; a very refined electrocoagulation needle set rather than a novel energy source.

Origin

South Korea (Agnes Medical Co., Ltd.); US distribution via Agnes America / Aesthetic Management Partners.

FDA & regulatory status

FDA status under reviewRegulatory status not yet verified

What it's actually cleared for:

Verified: K203013 cleared AGNES for dermatological and general surgical procedures for electrocoagulation and hemostasis — eye bags and acne-gland work are off-label uses of that clearance; more recent filings (K243713, K250217) exist and are worth reviewing for current labeling.

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

Treatment economics

What practices charge

Eye-bag treatment $1,500-3,500 per session, most patients 1-2 sessions — positioned against $4,000-7,000 lower-bleph surgery. Acne (gland ablation) $500-1,200 per session over 2-3; jowl/submental contouring $1,200-2,500.

Consumables & recurring cost

Single-use needle tips; modest per-case cost (generally under ~$100 each — verify with AMP); niche volume keeps annual spend low five figures or less.

Ideal for

Best-fit practice

Derm, oculoplastic, and cosmetic-surgery-adjacent practices that can clinically own periorbital work, or medspas with strong acne clientele wanting a "we can actually stop the recurring cyst" offer. Patients: 30s-60s eye-bag candidates avoiding surgery; 20s-40s stubborn-acne patients who've cycled through everything.

Compliance

Medical director & delegation

Class II electrosurgical device; periorbital fat coagulation is closer to a medical procedure than a facial — most practices keep it physician- or NP/PA-performed rather than delegating.

Contraindications & screening

Pacemakers/implanted electronics, pregnancy, active infection, keloid propensity, anticoagulation issues for periorbital work, severe skin-excess cases that truly need surgery.

Ownership

Warranty & service

~1-year warranty through the US distributor with extended options — verify terms with Aesthetic Management Partners including loaner availability; service depth is distributor-dependent.

Resale & used market

Thin, specialist-driven used market — infrequent listings, narrow buyer pool, slower liquidation but reasonable price retention given low unit volume.