Rohrer Aesthetics Pixel8-RF
RF Microneedling · Bipolar RF microneedling
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $67,495 (Rohrer-advertised price)Reported source: Manufacturer-provided · Sep 23, 2026
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA ClearedK233147
- 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: Sep 23, 2026
·FDA database · Updated Sep 23, 2026Read FDA-cleared indicationsExact wording from 1 FDA record
K233147 (Rohrer Aesthetics, 2023)
The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 23, 2026 · How we verify
Axis runs $0–$67,495. 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: Chartwell Investments (Chief Capital) and Tamarix Equity Partners, via Blue Ocean Aesthetics Holdings (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 | Bipolar RF microneedling |
| FDA status | FDA Cleared |
| 510(k) citation | K233147 |
| New price range | $67,495 (Rohrer-advertised price) |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2019 |
| Latest price source dated | Sep 23, 2026 |
| Manufacturer-source documents checked | Not published |
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Sep 23, 2026The FDA decision names PiXel8-RF and Rohrer Aesthetics. The summary distinguishes its 4 MHz system from the 2 MHz predicate K180654. Decision and indications: FDA document. Checked September 23, 2026. Cosmetic marketing claims are not additional cleared indications.K233147 names PiXel8-RF, cleared October 25, 2023. It covers the 4 MHz RF system for the indications quoted below. K180654 is the earlier 2 MHz PINXEL-RF predicate; K233143 covers the separate PiXel8-Reveal RF/Er:YAG system. Neither is presented as an additional clearance for this configuration. Checked September 23, 2026.
FDA-cleared indications (verbatim)
K233147 (Rohrer Aesthetics, 2023)
The PiXel8-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF Microneedling — Bipolar RF microneedling
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
Initiated Oct 15, 2025
Scope as FDA lists it
Applies to RF microneedling devices used for dermatologic or aesthetic procedures intended to improve the appearance of the skin. FDA is aware of reports of burns, scarring, fat loss, disfigurement and nerve damage, and of injuries needing surgical repair.
FDA advises providers to discuss these risks with patients and to report complications.
Reason and action
FDA advises providers to discuss these risks with patients before treatment, to use devices only as cleared, and to report complications to MedWatch. FDA did not name individual brands; the communication covers 510(k)-cleared RF microneedling devices as a class.
This communication applies to a class of devices, not to a specific unit or recall.
This is an FDA communication about a device class, not a recall of specific units; read the FDA notice for the reported risks and FDA's 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. This profile’s FDA record applies to the named device, not every similar-looking unit.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Consumable costs are not documented yet.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published Rohrer Aesthetics Pixel8-RF data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
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
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
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Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable 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
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.
History14 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 23, 2026
FDA indication
Source: Catalog update
September 23, 2026
Warranty & service
Source: Catalog update
September 23, 2026
FDA exact-model clearance
Corrected contradictory FDA prose and separated the current PiXel8-RF citation from its earlier predicate and the RF/Er:YAG combined system. Withheld unsupported clinical, earnings, consumable, service and resale prose; complete original values preserved here. Withholding does not establish every prior claim is false. Sourced price, price provenance, existing IFU records, reviews and commercial status unchanged.
Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233147
September 23, 2026
FDA K-numbers
K233147; K233143; K180654 → K233147
Source: Catalog update
September 23, 2026
Rohrer price evidence
Replaced the unsupported new-price range with the current exact-model product-page advertised price. Withheld the used range because reviewed source records and banked research do not establish that dated, condition-specific band. Original values are retained here; this does not imply there is no secondary market.
Source: https://rohreraesthetics.com/pixel8/
September 23, 2026
Used price range
12000-20000 → —
Source: Catalog update
September 23, 2026
New price range
25000-40000 → $67,495 (Rohrer-advertised price)
Source: Catalog update
September 22, 2026
Manufacturing origin evidence
Withdrew speculative manufacturing-origin wording without documented manufacturer-attribution evidence. Country of manufacture is not established by a brand headquarters, another model, or an assumed OEM relationship. Original text retained; no replacement origin asserted.
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Rohrer Aesthetics Pixel8-RF — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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