FDA 510(k) clearance — December 2008
Cleared for post-operative pain and edema in superficial soft tissue — the line every claim stays within.
What was cleared
In December 2008 the device received FDA 510(k) clearance for the adjunctive treatment of post-operative pain and edema in superficial soft tissue. That specific wording is the boundary of the cleared indication.
Why we hold the line at it
Every efficacy claim on this site stays inside that cleared indication. Where evidence exists for other uses, we describe it as evidence — not as a cleared claim. That discipline is what keeps the marketing defensible and the device on the right side of the regulation.
What this means for prescribers
A 510(k)-cleared Class II device can be prescribed, dispensed, and billed as a legitimate medical device — not a wellness product or an investigational device. Prescribers writing a prescription for SofPulse for post-operative pain and edema are prescribing within the cleared indication. There is no off-label discussion required, no IRB consideration, and no need to present it as experimental. The clearance is what makes the prescription straightforward and the RTM billing clean.
What this means for patients
A patient receiving a prescription for a 510(k)-cleared device is receiving something that has been evaluated by the FDA for both safety and substantial equivalence to a legally marketed device — the 510(k) standard. The device can be legally dispensed, and the prescription qualifies the purchase for HSA/FSA reimbursement under IRS Section 213(d) as a medical expense. For patients, the FDA clearance is not bureaucratic background — it is the gateway to pre-tax pricing and confidence that the device is not a wellness gadget.
Sources
- FDA 510(k) clearance, December 2008 — post-operative pain and edema, superficial soft tissue
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Ready to put SofPulse to work?
SofPulse is available by prescription. Patients can order online and pay with pre-tax HSA/FSA dollars; clinicians can start prescribing in minutes.
For education only — not medical advice, and not a substitute for a clinician's judgment. SofPulse is available by prescription only. Reimbursement figures reflect the 2026 CMS Physician Fee Schedule and vary by locality, payer, and documentation.