Ellman Pelleve S5 / GlideSafe
Monopolar RF Tightening · 4.0MHz continuous-wave RF wrinkle reduction
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New-unit reference · older model
- Not published
- Used asking price
- $3k–$10kSource not documented
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- 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. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 2 FDA records
K102698 (Ellman Int'L, Inc., 2011)
The Pellevd GlideSafeTM Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes [-IV.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K132665 (Ellman International, Inc., 2013)
Pellev4 Non-Ablative Wrinkle Treatment System The Pelleve§ Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
No new-unit price reference is published for this older model.
Axis runs $0–$10k. Reference figures, not current offers. Used asking prices are not completed-sale values.
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 | Ellman (Cynosure) |
|---|---|
| Company | Owner: Hahn & Company (South Korean private equity) (private equity owned, since 2024) · Distribution: direct |
| Parent company | Cynosure Lutronic |
| Brand owner | Ellman |
| Built by (OEM) | Ellman International |
| Category | Monopolar RF Tightening |
| Technology | 4.0MHz continuous-wave RF wrinkle reduction |
| FDA status | FDA Cleared |
| 510(k) citation | K102698, K132665 |
| New-unit reference (older model) | Not published |
| Used asking range | $3k–$10k |
| Consumables | Not published |
| Launch year | 2009 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Lunchtime tightening; absorbed via Cynosure acquisition
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K102698 (Ellman Int'L, Inc., 2011)
The Pellevd GlideSafeTM Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes [-IV.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K132665 (Ellman International, Inc., 2013)
Pellev4 Non-Ablative Wrinkle Treatment System The Pelleve§ Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Monopolar RF Tightening — 4.0MHz continuous-wave RF wrinkle reduction
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Cynosure Lutronic
Legal manufacturer: Ellman International (United States)
Applicant on the FDA record
Ellman Int'L, Inc.The 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-1624-2012Terminated — history
Initiated May 4, 2012 · Terminated Feb 12, 2016 · 1,088 units — worldwide distribution
Scope as FDA lists it
Pelleve Non-Ablative Wrinkle Treatment Handpiece, product codes D110FSHP and D115FSHP (reusable)
Historical: this recall is terminated. FDA recall record, checked 4 Sep 2026.
Check the FDA record for the affected serial numbers — this notice does not mean every unit is affected.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
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 Ellman Pelleve S5 / GlideSafe 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 midpoint of the published used asking range
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.
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.
History1 tracked change
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Ellman Pelleve S5 / GlideSafe — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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