Commercial terms and exact-model provenance remain subject to current source checks.
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Overview
AviClear is a Cutera platform in the facial aesthetics category. The manufacturer describes it as using 1726 nm infrared diode laser with contact cooling for inflammatory acne on intact skin in cleared treatment areas. Those specifications are company-reported, not an independent performance conclusion.
The FDA-cleared indication is treatment of mild to severe inflammatory acne vulgaris. Claims about durability or comparative performance require separate clinical evidence. The cited FDA records establish only the device names, classifications, or indications stated in those records. They do not establish comparative superiority, outcomes for every patient, or current commercial terms.
Before purchase, request the exact model, cleared indications, software version, handpieces, service coverage, training, and a written quote. Pricing and operating economics remain unknown where a current source packet was not available.
TREATMENT AREAS
Inflammatory acne on intact skin in cleared treatment areas
TREATMENT TIME
Cutera describes approximately 30-minute sessions
SESSIONS
Cutera describes a three-session series; individual care varies
PER SESSION
Practice-set; no verified range
CONSUMABLES/YR
Not publicly itemized
MAINTENANCE/YR
Service quote required
Pros & Cons
Pros
FDA 510(k) names the exact 1726 nm system and acne indication
The manufacturer publishes contraindications, warnings, and possible adverse events
Contact cooling is integrated into the treatment handpiece
The device creates a non-drug acne treatment option for a defined indication
Cons
Current acquisition and service pricing are not public in the reviewed sources
Cutera cites data on file for several outcome claims
Possible adverse events include discomfort, edema, blistering, pigment change, infection, and scarring
The cleared indication does not establish equivalence to oral or topical acne treatment pathways
Clinical Evidence
FDA K213461 documents the device and indication. The reviewed Cutera page relies partly on company data on file, so independent effect size and durability remain a research task.
This profile does not treat a clearance record or manufacturer page as proof of superior outcomes. Match each clinical claim to the exact model, indication, study design, sample size, source date, and funding disclosure.
The current packet supports product identification and the limited regulatory statements shown here. Independent comparative effectiveness, local demand, and practice economics remain open diligence questions.
ROI Analysis
Device Pulse is not publishing a payback estimate for AviClear because current transaction price, financing, service, consumables, staffing, and local patient demand have not been independently verified.
Build the decision from your written quote. Model conservative monthly treatment volume, realized revenue per treatment, consumables, operator time, service, downtime, financing, and patient-acquisition cost. Run a downside case before using the model in a purchase decision.
A manufacturer projection is an input to test, not a forecast. Ask for every assumption in writing and compare it with your scheduling capacity and historical conversion data.
Best For
Dermatology practices evaluating an energy-based acne service line after confirming patient selection, current labeling, staff training, service terms, and conservative demand assumptions.
Use that as a short-list hypothesis. Confirm the exact indication, patient mix, operator training, local service, workflow, and written commercial terms before deciding that the platform fits the practice.
Buying Guide
Request a written, model-specific quote for AviClear. Separate the console, handpieces, software, training, installation, warranty, service, and recurring supplies or licensing.
Confirm the serial number, current software, cleared indications, ownership-transfer terms, parts availability, response time, and local service provider. Do not assume a product-page feature applies to every configuration.
Ask Cutera to identify which statements are specifications, which are company-reported claims, and which are supported by independent clinical evidence. Keep those records with the final contract.
Alternatives to review
Use these profiles to build a short list. An alternative listing is not a claim of equivalence or superiority.
Clear + Brilliant Touch: Dermatology and aesthetic practices comparing a lower-intensity fractional resurfacing option and willing to verify treatment-credit economics and exact handpie
NEW Manufacturer quote required · USED No reconciled dated sample
BBL HEROic: Established dermatology or aesthetic practices comparing a multi-application light platform and prepared to verify the exact console, filters, current labeling,
NEW Manufacturer quote required · USED No reconciled dated sample
MOXI: Dermatology and aesthetic practices comparing a lower-intensity 1927 nm resurfacing workflow and willing to verify tip costs, current labeling, training, and co
NEW Manufacturer quote required · USED No reconciled dated sample
A current acquisition price was not published in the reviewed source packet. Request a written quote from Cutera that separates the console, handpieces, software, training, installation, warranty, service, and recurring supplies.
What is the FDA status of AviClear?
FDA 510(k) K213461 identifies AviClear as a 1726 nm dermatology laser indicated for mild to severe inflammatory acne vulgaris.
What evidence supports this AviClear profile?
FDA K213461 documents the device and indication. The reviewed Cutera page relies partly on company data on file, so independent effect size and durability remain a research task. The source packet separates FDA public records from manufacturer-reported product information. It does not establish comparative superiority.
Which practices should evaluate AviClear?
Dermatology practices evaluating an energy-based acne service line after confirming patient selection, current labeling, staff training, service terms, and conservative demand assumptions. That is an editorial fit question, not a clinical or financial conclusion.
What should a buyer verify before ordering AviClear?
Verify the exact model, cleared indications, handpieces, software, serial-number history, training, service response, warranty, ownership-transfer terms, recurring supplies, and every commercial assumption in writing.
What are the main limitations in this AviClear profile?
Current limitations include: Current acquisition and service pricing are not public in the reviewed sources; Cutera cites data on file for several outcome claims; Possible adverse events include discomfort, edema, blistering, pigment change, infection, and scarring. Recheck the dated primary sources before using the profile in a purchase decision.
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