Devices & drugs
Warning letter 712715, Diowave lasers
FDA told Technological Medical Advancements LLC of West Palm Beach that two Diowave laser systems were being sold for uses and with a technology that fall outside the infrared-lamp exemption the firm has relied on — including claims that the beam has no heat and that it “actually heals living tissue.”
The inspection ran April 9–21, 2025. The products are the Diowave 100 WLS and 250 WLS. Infrared lamps at 21 CFR 890.5500 are 510(k)-exempt when they provide topical heating for temporary relief of minor pain and spasm. The firm’s own brochures, FDA quotes, say stealth micro-pulse “allows you to hold a hand piece static over a focal pathology without heating tissue,” and that “laser therapy is the only treatment in medicine that actually heals living tissue.” Other claims in the letter include peripheral neuropathy, wound care, disc pathology, and amplifying regenerative-medicine treatments. The firm does have a clearance, K121363, limited to topical heating. Promotion beyond that, FDA writes, is a major change in intended use and a technological change that needs a new 510(k).
The quality-system half of the letter is a stack of repeats. Investigators could not get a design-history file or a risk file from the contract manufacturer. The firm had opened no CAPAs after fourteen observations in 2021, thirteen in 2020, and a twelve-item FDA letter in June 2020. There were no quality audits in 2023 or 2024, no management review in 2024, and no procedure for nonconforming product. The labels, FDA says, also lack a unique device identifier.
FDA asked the firm to cease commercial distribution for the uses discussed in the letter.
fda.gov — Technological Medical Advancements LLC — 712715 — 09/26/2025
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. A warning letter is an administrative notice, not a court judgment. Redaction marks such as (b)(4) are FDA’s.