Jessica abreu
Core Nutrition and Wellness
Attested owner
Model: XerfWould buy againResults 5/5Reliability 5/5Service & support 5/5Training 5/5
Cynosure Lutronic XERF
Monopolar RF skin tightening
Technology: Monopolar Radiofrequency
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
Current5.0(1 review)Small sample
At a glance
- New price
- Not published
- FDA status
Record scope: 510(k): K251327 (XERF, Lutronic, decision 11 Aug 2025). Checked 4 Sep 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 scopeK251327
- 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.
1 of 1 reviewers would buy again
Read FDA-cleared indicationsExact wording from 1 FDA record
K251327 (Lutronic Corporation, 2025)
XERF is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 1, 2026 · How we verify
New-equipment price not yet documented
For a complete budget, ask for an itemized quote covering the device, accessories, training and service.
Price sourcesSources, dates and configurations
No price sources are documented yet. Ask the seller for a current, itemized quote.
Key factsCompany, specifications and verification dates
| Manufacturer | Cynosure Lutronic |
|---|---|
| Company | Owner: Hahn & Company (South Korean private equity) (private equity owned, since 2024) · Distribution: direct |
| Parent company | Cynosure Lutronic |
| Brand owner | Cynosure Lutronic |
| Built by (OEM) | Cynosure LLC |
| Category | Monopolar RF skin tightening |
| Technology | Monopolar RF skin tightening |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K251327 |
| New price range | Not published |
| Used price reference | Not published |
| Consumables | Not published |
| Launch year | Not published |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
XERF is a Cynosure Lutronic monopolar RF system using multiple frequencies. The manufacturer markets it for skin tightening through soft-tissue coagulation.
Its stated US intended use is electrocoagulation and hemostasis in dermatologic and general surgical procedures.
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA record cited — see scopeAuthorized via 510(k)
510(k): K251327 (XERF, Lutronic, decision 11 Aug 2025). Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K251327 (Lutronic Corporation, 2025)
XERF is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Radiofrequency — monopolar — Monopolar RF skin tightening
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Cynosure Lutronic
Legal manufacturer: Cynosure LLC (United States)
Applicant on the FDA record
Lutronic CorporationThe 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.
- RecallZ-0146-2026Class IIOpen
Initiated Sep 4, 2025 · 7,490 units
Scope as FDA lists it
XERF EFFECTOR 60. Electrosurgical unit.
Affected catalog numbers 1101210000, 1101210100 and 1101210200; UDI-DI 08809447657752; lots MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03 and MP60J25H01. Scope covers units manufactured between 1 April 2025 and 20 August 2025.
Distribution: Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
Reason and action
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
FDA recall record, checked 4 Sep 2026.
Check the FDA record for affected models, lots or serial numbers and the required action.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
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 Cynosure Lutronic XERF. Published figures appear where available; review them before using the estimate.
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.
New price not published — enter the number on your quote.
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
Required — enter your cost; missing data does not mean $0.
Required — include staff time and your own time. Enter 0 only to explicitly exclude labor from this estimate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter purchase price, 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
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
Write a reviewDevice user rating 5.0 · 1 reviewSmall sample: fewer than 10 scored reviews.
- Would buy again
- 1 of 1
- Overall satisfaction
- 5.0/5
- Service & support
- 5.0/5
- Reliability
- 5.0/5
- Results
- 5.0/5
- Training
- 5.0/5
1 response
1 response
1 response
1 response
1 response
1 response
1 owner or operator review. Overall satisfaction is scored separately from the categories.
Purchase price, treatment volume and payback medians appear after 20 owner responses with economic data. Methodology.
Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
Classys EVERESSE (Volnewmer)
Monopolar RF skin tightening
New-equipment price not yet documented.
Research comparisons
Includes current and older models.
History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
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://www.cynosure.com/xerf/
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
September 4, 2026
FDA source URL
Source: Catalog update
Cite this data: The Aesthetic Index, "Cynosure Lutronic XERF — pricing, FDA status and cost to own", aestheticindex.co (accessed November 2, 2026).
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Device and company names are trademarks of their respective owners. The Aesthetic Index is not affiliated with or endorsed by any manufacturer, distributor or lender named here, except as disclosed. Price figures are references, not current offers. Check each device’s source notes. Not medical, legal or regulatory advice.