Rohrer Aesthetics PiX:E
RF Microneedling · RF microneedling with Er:YAG resurfacing
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $79,995 (Rohrer-advertised price)Reported source: Manufacturer-provided · Oct 1, 2026
- FDA status
Record scope: FDA's device listing links the proprietary name Pix-E to K233143, cleared February 2, 2024 under the name PiXel8-Reveal. The clearance covers the combined RF and Er:YAG system, with separate indications for each handpiece. See the FDA document for the exact indications. This is not the standalone PiXel8-RF clearance K233147. Checked September 23, 2026.
- Supplies & recurring costs
- Supply details not yet documented.
Sources and data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA record cited — see scopeK233143
- Used asking prices
- Not verified
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers.
Latest price source dated: Oct 1, 2026
·FDA database · Updated Sep 23, 2026Read FDA-cleared indicationsExact wording from 1 FDA record
K233143 (Rohrer Aesthetics, 2024)
The PiXel8-Reveal contains two handpieces, each of which has its own indications for use. The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 1, 2026 · How we verify
Axis runs $0–$79,995. Reference figures, not current offers.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Rohrer Aesthetics |
|---|---|
| Company | Owner: Blue Ocean Holding (private equity owned, since 2022) · Distribution: direct |
| Parent company | Rohrer Aesthetics |
| Brand owner | Rohrer Aesthetics |
| Built by (OEM) | Rohrer Aesthetics LLC |
| Category | RF Microneedling |
| Technology | RF microneedling with Er:YAG resurfacing |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K233143 |
| New price range | $79,995 (Rohrer-advertised price) |
| Used price reference | Not published |
| Consumables | Not published |
| Launch year | Not published |
| Latest price source dated | Oct 1, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
PiX:E combines a PiXel8-RF handpiece with an Er:YAG resurfacing handpiece. Each handpiece has separate indications and operating requirements.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Sep 23, 2026Exact-model bridge: FDA registration/listing names Pix-E under K233143: FDA listing. The FDA decision and summary name PiXel8-Reveal (February 2, 2024), with RF and Er:YAG handpieces. Summary: FDA document. Listing dataset last updated September 14, 2026; checked September 23. Manufacturer marketing alone was not used to establish clearance.FDA's device listing links the proprietary name Pix-E to K233143, cleared February 2, 2024 under the name PiXel8-Reveal. The clearance covers the combined RF and Er:YAG system, with separate indications for each handpiece. See the FDA document for the exact indications. This is not the standalone PiXel8-RF clearance K233147. Checked September 23, 2026.
FDA-cleared indications (verbatim)
K233143 (Rohrer Aesthetics, 2024)
The PiXel8-Reveal contains two handpieces, each of which has its own indications for use. The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF Microneedling — RF microneedling with Er:YAG resurfacing
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Rohrer Aesthetics
Legal manufacturer: Rohrer Aesthetics LLC (United States)
Applicant on the FDA record
Rohrer AestheticsThe applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
FDA safety actions
Recorded recalls, warning letters and safety communications. Terminated actions remain visible as history.
How we report safety actionsChecked 7 Sep 2026 against FDA enforcement data dated 2 Sep 2026.
- FDA safety communicationFDA safety communication, issued 15 October 2025Open
Issued Oct 15, 2025
Scope as FDA lists it
FDA reports serious complications with certain uses of RF microneedling for aesthetic skin procedures, including burns, scarring, fat loss, disfigurement and nerve damage. Some injuries have required surgical repair or other medical treatment.
Reason and action
Discuss potential benefits and risks with a licensed clinician trained in RF microneedling. FDA recommends reporting complications and says these devices should not be used at home.
Read the FDA notice for the devices or procedures covered, reported risks and recommendations.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Look-alike devices
Comparing an unbranded RF microneedling unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Rohrer Aesthetics LLC
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
- Support: Get written warranty, training, consumables and service terms from the seller.
- Financing: Confirm availability for the exact unit before including it in your budget.
We do not profile these unbranded units or verify their support and financing terms. Any FDA record cited here must be read for its exact model and scope; it does not automatically cover similar-looking units.
Treatment & running costs
Treatment and running-cost details aren’t documented yet.
Ask the supplier for the session schedule, supplies per treatment and annual service costs.
Use your own figures in the calculatorPayback calculatorEnter your quote, volume and running costs
Estimate your payback
Enter your quote and treatment costs for Rohrer Aesthetics PiX:E. Published figures appear where available; review them before using the estimate.
Start from
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
Pre-filled from the published new-price reference
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No sourced per-session price on file — enter what you charge.
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Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment, labor cost per treatment to see contribution and a payback range.
This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
Warranty & serviceWhat to confirm in writing before you buy
Published warranty details
Device warranty: one year from delivery, subject to Rohrer’s coverage and exclusions.
Accessories have separate terms. Extended service is optional and separately priced.
Confirm coverage in your written quote.
Source notes
Section 7 names this model. Published sale terms checked September 29, 2026.
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
Chains using this device
A chain listing does not establish availability at every location.
No confirmed chain deployments recorded yet.
Owner & operator reviews
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
Aesthetics Biomedical Vivace
RF Microneedling
New-equipment price reference
$35k–$55k
Source not documentedCheck the profile for configuration and price details.
History12 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 1, 2026
Price-source recheck
Rechecked this linked public price and exact configuration on October 1, 2026. Advertised asking price, not a verified transaction. Only this price field was reviewed.
Source: https://rohreraesthetics.com/pixe/
October 1, 2026
Sourced profile overview
Added a neutral overview from the linked manufacturer or official US distributor source. This is field-specific sourcing, not verification of every other profile field.
Source: https://rohreraesthetics.com/indications-for-use/
September 29, 2026
Rohrer warranty terms and product link
Added missing published warranty summary and official product link; all price and regulatory fields retained.
Source: https://rohreraesthetics.com/terms/
September 29, 2026
Warranty & service
Source: Catalog update
September 28, 2026
Safety communication readability
Shortened the October 15, 2025 RF microneedling communication summary after checking the FDA source. Kept all five reported complication types, possible surgical/medical intervention, clinician risk discussion, trained provider and adverse-event reporting guidance. Removed duplicate class-scope text because the public section already labels this as a class communication, not a unit recall. Did not change device associations, action identifiers, dates, status or source. This editorial check does not claim a new complete FDA enforcement sweep.
Source: https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication
September 23, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233143
Source: Catalog update
September 23, 2026
FDA exact-model clearance
Corrected the previous no-clearance-identified result after matching FDA’s Pix-E listing to K233143 (PiXel8-Reveal). The prior search missed the alternate regulatory name. Exact prior values are preserved here. Prices, reviews and commercial status are unchanged.
Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233143
September 23, 2026
FDA status
Registered-Cosmetic → Cleared
Source: Catalog update
September 23, 2026
FDA K-numbers
K233143
Source: Catalog update
September 23, 2026
New price range
$79,995 (Rohrer-advertised price)
Source: Catalog update
September 23, 2026
Rohrer price evidence
Added the exact-model advertised new price from Rohrer’s current US product page, with source and observation date. No previous price was on file. The used price remains unknown.
Source: https://rohreraesthetics.com/pixe/
September 8, 2026
FDA status
Unknown → Registered-Cosmetic
Source: Record correction
Cite this data: The Aesthetic Index, "Rohrer Aesthetics PiX:E — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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