Equipment profile · Cutera
Cutera AviClear: Price, Specs, FDA Clearance and Alternatives
AviClear is Cutera’s 1726 nm laser for practices that want to offer a medication-free acne treatment. It heats the oil glands while contact cooling protects the skin, and Cutera says it was the first energy device FDA cleared for mild to severe inflammatory acne. A course is three sessions.
The short answer
AviClear is FDA cleared for long-term treatment of mild to severe inflammatory acne. In Cutera’s 104-patient trial, three treatments cut median inflammatory lesion counts by 55.9% at 12 weeks; the trial had no control group. Cutera doesn’t publish prices and has offered both a lease with treatment fees and an upfront purchase.
Who should buy an AviClear?
Shortlist it if
- Acne patients are a large share of your practice, including teens and adults who want to avoid isotretinoin.
- You can sell a three-session series and track each patient’s lesion counts.
- Cutera commits in writing to service, parts and treatment fees for your full term.
Compare another option if
- You want acne as one of many services on a single console: compare Stellar M22 or BBL HEROic.
- You also want vascular and pigment work from the same purchase: compare Cutera’s excel V+.
Our take: is AviClear worth it for a med spa?
Buy AviClear only if your acne demand can keep a single-purpose system busy. It treats one condition, and its published results, while strong, come from studies without control groups and with Cutera-affiliated authors.
Model the economics both ways: purchase price plus the lower per-treatment cost, against the lease fee plus treatment fees. Cutera’s 2025 restructuring makes written service and fee terms for your whole term essential.
Document-based buying analysis. Not a NuWays MD hands-on test of this device.
AviClear specifications at a glance
Before you compare
| Specification | AviClear | What it means for your practice |
|---|---|---|
| Laser | 1726 nm diode laser that heats sebum in the oil glands | A single-purpose system; plan around acne demand, not general skin services. |
| Cooling | Temperature-controlled contact cooling before, during and after each pulse (AviCool) | Treated without numbing in the trial; patients rated discomfort about 5 out of 10. |
| Handpieces | Universal handpiece; a Large handpiece cleared in 2025 with a 3 x 3 mm square spot and arrays of up to 25 spots | Ask whether the Large handpiece is included or an upgrade. |
| Treatment course | Three sessions 2 to 5 weeks apart in the FDA trial; Cutera describes 30-minute sessions | Price the series, and plan rooms around 30-minute visits. |
| Safety interlocks | Skin-contact pressure sensors; the laser fires only with skin contact and the footswitch pressed | |
| Skin types | Published trial enrolled skin types II to VI, with similar results and comfort across types | Relevant if your patients span a wide range of skin tones. |
Sources: Cutera · FDA 510(k) K213461 · FDA 510(k) K251149.
See it next to the alternativesSpecs, cleared uses and ownership questions in one table.
AviClear today vs. the 2022 launch: what changed?
Cutera has changed both how AviClear is sold and the hardware since launch. Check which of these a quote, or a used system, includes.
| Feature | AviClear now | At the 2022 launch |
|---|---|---|
| Ownership | Upfront purchase option, added late 2023 | Lease with a fixed annual license fee |
| Treatment billing | Per treatment cycle, no patient QR codes | Per patient, with patient-specific QR codes |
| Handpieces | Universal plus a Large handpiece (2025) | One handpiece |
| Post-treatment cooling | 1 second | 2 seconds |
| FDA claim | Long-term treatment of mild to severe inflammatory acne | Mild to severe inflammatory acne |
Sources: Cutera 2022 annual report (SEC Form 10-K) · Cutera third-quarter 2023 results (SEC Form 8-K, exhibit 99.1) · FDA 510(k) K251149 · FDA 510(k) K230660.
What is the AviClear FDA cleared for?
Each 510(k) number links to its record in the FDA database. The summary PDFs are listed under Sources.
510(k) K251149 (AviClear Laser System), cleared July 11, 2025. Product code GEX; Class II medical device. Adds the Large handpiece and shortens post-treatment cooling from 2 seconds to 1, supported by a multicenter safety study.
Source: FDA 510(k) K251149.
510(k) K230660 (AviClear Laser System), cleared June 6, 2023. Product code GEX; Class II medical device. Adds “long-term” to the claim, based on 52-week follow-up of the original trial, where 91.5% of subjects met the success definition of at least 50% fewer inflammatory lesions.
| Wavelength | Cleared uses (summarized) |
|---|---|
| 1726 nm | Long-term treatment of mild to severe inflammatory acne vulgaris. |
Source: FDA 510(k) K230660.
510(k) K213461 (AviClear Laser System), cleared March 24, 2022. Product code GEX; Class II medical device. A 104-patient trial at 7 US sites with up to three treatments; median inflammatory lesion counts fell 55.9% at 12 weeks. Predicate: Candela Smoothbeam (K041242).
| Wavelength | Cleared uses (summarized) |
|---|---|
| 1726 nm | Treatment of mild to severe inflammatory acne vulgaris. |
Source: FDA 510(k) K213461.
Clearance describes what a device may be marketed for; it does not predict results for a given patient.
- The trial had no control group, and the one-year figure comes from the 71 patients who returned at 52 weeks (JAAD, 2026).
AviClear clinical studies
Published studies we found on this system, its earlier models and related technology, each labeled by what it tested. Most are small, and some have manufacturer-affiliated authors, so use them to frame questions for the demo rather than as proof of results.
What we found: 2 on this system.
- This systemNovel 1726 nm laser demonstrates durable therapeutic outcomes and tolerability for moderate-to-severe acne across skin typesThree treatments in skin types II to VI; 79.8% had at least 50% fewer inflammatory lesions at 12 weeks and 87.3% at 26 weeks. No control group; a Cutera employee and Cutera advisers are authors.
- This systemSafe and effective acne treatment across skin types with a 1726 nm sebum-selective laser: One year data from a prospective multicenter study91.5% of the 71 patients seen at one year had at least 50% fewer inflammatory lesions, and 66.2% were clear or almost clear. Several authors are Cutera consultants or investigators.
Links open the PubMed record.
How much does an AviClear cost?
| Price evidence | What we found |
|---|---|
| New system (manufacturer quote) | Cutera does not publish prices, and we found no reliable public price. Ask for both the purchase price and the per-treatment cost, since together they set your margin. |
| Used (asking prices) | Not reviewed for this profile. Ask Cutera whether a used AviClear can be transferred and what treatment fees apply. |
| Documented sale prices | None found. |
What ownership adds after purchase
| Cost area | What to confirm |
|---|---|
| Treatment fees | Under the lease model each treatment carries a fee to Cutera; the purchase option lowers it. Get the per-treatment cost in writing. |
| Hardware level | Ask whether the Large handpiece and the 2023 hardware and software upgrade are included. |
| Marketing support | Cutera has offered cooperative marketing for AviClear; ask what is included and for how long. |
| Service | Get service and parts terms in writing for the full term, given Cutera’s 2025 restructuring. |
AviClear alternatives to compare
| Device | Technology | Why compare it |
|---|---|---|
| Lumenis Stellar M22 | Pulsed light and modular laser platform | IPL with a dedicated acne filter, plus lasers for pigment, vessels and texture on one console. |
| Sciton BBL HEROic | Broadband pulsed light; not a laser | Sciton’s broadband light with an acne mode alongside pigment and redness treatments. |
| Cutera excel V+ | 532 / 1064 nm laser | Cutera’s 532 and 1064 nm laser; its 1064 nm wavelength is cleared for mild to moderate inflammatory acne. |
Different technologies are not interchangeable. Compare configurations, cleared uses and ownership costs before you book demos.
Questions to ask before you sign
- Is this a purchase or a lease, and what does each treatment cost under the agreement?
- Is the Large handpiece included, and is the system on current hardware and software?
- Does the agreement require a minimum number of treatments?
- What marketing support and training come with the system, and for how long?
- Who services the system, and what are the parts and service terms after Cutera’s 2025 restructuring?
- What is the total with tax, freight, installation and financing?
Plan the purchase
Plan your AviClear purchase.
- Compare it side by side with its closest alternatives.
- Check what each quote includes: configuration, supplies, service and financing.
- Model the monthly payment against realistic treatment volume in the ROI calculator.
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Sources
Show all 7 sources
- Cutera: AviClear (November 7, 2026). Checked November 7, 2026.
- Cutera 2022 annual report (SEC Form 10-K) (April 7, 2023). Checked November 7, 2026.
- Cutera third-quarter 2023 results (SEC Form 8-K, exhibit 99.1) (November 8, 2023). Checked November 7, 2026.
- Cutera restructuring announcement (SEC Form 8-K, exhibit 99.2) (March 5, 2025). Checked November 7, 2026.
- FDA 510(k) K213461: AviClear Laser System (March 24, 2022). Checked November 7, 2026.
- FDA 510(k) K230660: AviClear Laser System (June 6, 2023). Checked November 7, 2026.
- FDA 510(k) K251149: AviClear Laser System (July 11, 2025). Checked November 7, 2026.