Venus AI.ME
Micro-coring · Robotic micro-coring with hollow needle punches
Technology: Micro-coring
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- Not published
- FDA status
Record scope: 510(k): K221011. 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 scopeK221011
- 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.
Read FDA-cleared indicationsExact wording from 1 FDA record
K221011 (Venus Concept USA, Inc., 2022)
The AI.ME system is indicated for fractional skin resurfacing.
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 | Venus Concept |
|---|---|
| Company | Owner: Funds managed by Madryn Asset Management (private equity owned, since 2026) · Distribution: direct |
| Parent company | Venus Concept |
| Brand owner | Venus Concept |
| Built by (OEM) | Venus Concept Inc. |
| Category | Micro-coring |
| Technology | Robotic micro-coring with hollow needle punches |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K221011 |
| 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
Venus AI.ME uses robot-controlled micro-coring with a disposable array of hollow punches to remove small skin cores. This is a mechanical tissue-removal technology.
Confirm the applicable treatment labeling, training and consumables.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K221011. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K221011 (Venus Concept USA, Inc., 2022)
The AI.ME system is indicated for fractional skin resurfacing.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF Microneedling — Powered microneedling device
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Venus Concept
Legal manufacturer: Venus Concept Inc. (United States)
Applicant on the FDA record
Venus Concept Ltd.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
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 Venus AI.ME. 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
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
No current alternatives identified in the catalog yet. Browse current models
History8 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 1, 2026
Profile overview and accuracy audit
Added a neutral sourced overview. This is field-specific sourcing, not verification of every other profile field or an endorsement of health-outcome claims.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221011.pdf
September 22, 2026
Safety communication device linkage
Held unsupported AI.ME association to the RF microneedling safety communication. K221011 describes robotic micro-coring. This corrects catalog applicability, not the FDA notice or the existence of device risks.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221011.pdf
September 22, 2026
Exact-model treatment modality
Exact-model treatment modality corrected from the cited primary source. Prior catalog fields retained in this history entry. No review, price, availability or regulatory-status change.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221011.pdf
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, "Venus AI.ME — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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