Lumenis NuEra Tight
RF body contouring · Temperature-controlled monopolar RF
Technology: Monopolar Radiofrequency
At a glance
- New price
- $60k–$90kSource not documented
- Used asking price
- $20k–$45kSource not documented
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
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 6 FDA records
K200359 (Bios S.R.L., 2020)
The NuEra Tight RF Family is intended for: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K201239 (Bios S.R.L., 2020)
The NuEra Tight Family, EMS Model, is intended for: - improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; - strengthening, toning and firming of buttocks, thighs and calves; - improvement of muscle tone and firmness, for strengthening muscles in arms.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K210867 (Bios S.R.L., 2021)
The NuEra Tight RF Family is intended: to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation; * to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K223856 (Bios S.R.L., 2023)
The NuEra Tight RF and NuEra Tight RF Plus are intended: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K223907 (Bios S.R.L., 2023)
The NuEra Tight RF Model APMD145.M70-US is intended for: • to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation • to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K230755 (Bios S.R.L., 2023)
The NuEra Tight RF Model OptiStream is intended: - to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 4, 2026 · How we verify
Axis runs $0–$90k. 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 | Lumenis |
|---|---|
| Company | Owner: Baring Private Equity Asia (BPEA, now part of EQT) (private equity owned, since 2019) · Distribution: direct |
| Parent company | Lumenis |
| Brand owner | Lumenis |
| Built by (OEM) | Lumenis Be Ltd. |
| Category | Body Contouring |
| Technology | Temperature-controlled monopolar RF |
| FDA status | FDA Cleared |
| 510(k) citation | K200359, K201239, K210867, K223856, K223907, K230755 |
| New price range | $60k–$90k |
| Used asking range | $20k–$45k |
| Consumables | Not published |
| Launch year | 2019 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Multi-frequency depth targeting
How it worksTechnology and manufacturing
How the technology works
Monopolar RF with automatic temperature control — continuous surface thermal monitoring modulating output to hold target temp (typically 42-45C) for a set dwell time, removing operator guesswork.
Differentiator: selectable frequencies (roughly 470kHz up to several MHz) shifting heating depth — higher frequencies concentrate superficially for skin/wrinkle work, lower frequencies push deeper for subcutaneous/cellulite-appearance and therapeutic heating.
Labeled uses: non-invasive wrinkle treatment, temporary cellulite-appearance reduction, deep tissue heating for pain/circulation/muscle spasm. Courses of 4-8 weekly sessions with maintenance; best on mild-moderate laxity and as a skin-quality adjunct for post-weight-loss patients.
Patented technology
APC automatic power/temperature control (closed-loop thermistor feedback — genuinely valuable for reproducibility and burn safety) and multi-frequency depth-tuning ("FocalRF") — straightforward RF physics productized into presets. Neither is exotic; both make the device safer to run with junior staff.
Origin
OEM-manufactured in Italy by Bios S.r.l. and distributed under the Lumenis brand — the FDA filings are in Bios's name, which tells you the real supply chain.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Launch 2019 · Clearance 2020 · Clearance 2021 · Clearance 2023 · K200359; K201239; K210867; K223856; K223907; K230755
510(k): K200359, with family clearances K201239, K210867, K223856, K223907 and K230755; applicant Bios S.R.L. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K200359 (Bios S.R.L., 2020)
The NuEra Tight RF Family is intended for: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K201239 (Bios S.R.L., 2020)
The NuEra Tight Family, EMS Model, is intended for: - improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; - strengthening, toning and firming of buttocks, thighs and calves; - improvement of muscle tone and firmness, for strengthening muscles in arms.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K210867 (Bios S.R.L., 2021)
The NuEra Tight RF Family is intended: to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation; * to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K223856 (Bios S.R.L., 2023)
The NuEra Tight RF and NuEra Tight RF Plus are intended: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K223907 (Bios S.R.L., 2023)
The NuEra Tight RF Model APMD145.M70-US is intended for: • to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation • to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K230755 (Bios S.R.L., 2023)
The NuEra Tight RF Model OptiStream is intended: - to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Radiofrequency — monopolar — Temperature-controlled monopolar RF
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Lumenis
Legal manufacturer: Lumenis Be Ltd. (Israel)
Applicant on the FDA record
Bios S.R.L.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.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
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 Lumenis NuEra Tight 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.
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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.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Pacemakers/defibrillators and electronic implants, pregnancy, metal in the field, malignancy, impaired thermal sensation. Safe across all Fitzpatrick types.
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.
History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
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
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Lumenis NuEra Tight — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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