OxyHealth Vitaeris 320
Hyperbaric (mild) · Soft-shell mHBOT chamber (1.3 ATA)
Classification & configurations
Category group: Facial & wellness (hydradermabrasion, facials, recovery)
At a glance
- New price
- $20k–$23kSource not documented
- Used asking price
- $10k–$15kSource 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
- FDA
- FDA ClearedK001409
- 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.
Page updated: September 18, 2026 · How we verify
Axis runs $0–$23k. 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 | OxyHealth |
|---|---|
| Company | Not published |
| Parent company | OxyHealth |
| Brand owner | OxyHealth |
| Built by (OEM) | OxyHealth LLC |
| Category | Hyperbaric (mild) |
| Technology | Soft-shell mHBOT chamber (1.3 ATA) |
| FDA status | FDA Cleared |
| 510(k) citation | K001409 |
| New price range | $20k–$23k |
| Used asking range | $10k–$15k |
| Consumables | Not published |
| Launch year | 2005 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Most common medspa soft chamber
How it worksTechnology and manufacturing
How the technology works
Hard-chamber hyperbaric oxygen at 2.0+ ATA has genuine, UHMS-recognized evidence for about 14 medical indications (wound healing, decompression sickness, radiation injury).
The evidence that 1.3 ATA with ambient air or a concentrator delivers those same benefits is thin — several controlled trials have used 1.3 ATA as the sham arm.
There are intriguing signals in TBI, long-COVID, and recovery literature, but honest framing is: plausible mechanism, weak-to-moderate clinical evidence at this pressure, strong placebo-plus-relaxation component.
Market it as recovery and wellness, not as treatment for autism, Lyme, or neurologic disease, which FDA has addressed in its letter to health care providers on safe use of hyperbaric oxygen therapy devices (25 August 2025: https://www.fda.gov/medical-devices/letters-health-care-providers/follow-instructions-safe-use-hyperbaric-oxygen-therapy-devices-letter-health-care-providers).
Patented technology
OxyHealth's double-bladder 44-oz urethane-coated polyester construction with external frame-free design, dual-redundancy pressure valves, and its quiet oil-less compressor system; OxyHealth holds design patents across its chamber line and states it has the largest installed base (20,000+ chambers).
Origin
Santa Fe Springs, California, USA.
FDA & regulatory detailClearance timeline, authorization route and citation notes
AccessGUDID record 10856039006011 identifies Vitaeris 320 (model 15C37179), lists Hyperbaric Technologies, Inc., and links it to K001409. This is device-company-submitted identification data. The FDA clearance record uses the names Gamow Bag, Hyper Oxy, Hyper Oxy P/T and Pressure-Cizer. Verbatim cleared indications are not yet on file here; the identifier link does not establish additional treatment claims. Sources checked September 18, 2026.
FDA-cleared indications (verbatim)
Cleared indications not yet transcribed from the 510(k) record — see the linked FDA record.
Marketed for
Hyperbaric (mild) — Soft-shell mHBOT chamber (1.3 ATA)
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: OxyHealth
Legal manufacturer: OxyHealth LLC (United States)
Applicant on the FDA record
Hyperbaric Technologies, 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.
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 OxyHealth Vitaeris 320 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 new-price 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.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Untreated pneumothorax is the absolute contraindication; screen also for recent ear/sinus surgery or barotrauma risk, certain chemotherapy agents (bleomycin, doxorubicin), uncontrolled seizure disorders, and claustrophobia (practical, not medical).
Ear-clearing instruction on the first session prevents most adverse events you'll actually see.
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 reviewNo owner or operator reviews yet. Be the first →
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 18, 2026
FDA indication
Source: Catalog update
September 18, 2026
fda scope note
September 18 source audit: corrected conflicting model linkage; verbatim clearance indications remain missing. Existing FDA status and K-number retained.
Source: https://accessgudid.nlm.nih.gov/devices/10856039006011
September 18, 2026
fda search completed on
2026-09-08 → 2026-09-18
September 18 source audit: corrected conflicting model linkage; verbatim clearance indications remain missing. Existing FDA status and K-number retained.
Source: https://accessgudid.nlm.nih.gov/devices/10856039006011
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K001409
Source: Record correction
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
K001409
Source: Record correction
September 7, 2026
patented tech
Source: Catalog update — editorial sentences removed (neutral-voice standard, 7 Sep 2026)
September 4, 2026
science
Manufacturer-conduct language removed or restated as a dated, sourced fact.
Source: Editorial sweep 2026-09-04: manufacturer-conduct language neutralized
September 4, 2026
FDA status
No US 510(k) naming this model located; cleared assertion removed
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Source: Catalog update
September 4, 2026
FDA indication
Source: Catalog update
August 9, 2026
FDA status
Source: Catalog update
August 5, 2026
Warranty & service
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, "OxyHealth Vitaeris 320 — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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