FDA WARNING_LETTER - Curewave Lasers LLC - September 05, 2019

The FDA issued a Warning Letter to Curewave Medicore following an inspection from August 22 to September 5, 2019, identifying significant violations. The firm's Curewave Medicore device is adulterated because it lacks an approved premarket approval (PMA) or investigational device exemption. It is also misbranded for not submitting a 510(k) premarket notification.

Despite a 2017 FDA classification as Class II Exempt (21 CFR 890.5500, product code ILY) for topical heating, the firm markets the device for unapproved uses like "tissue regeneration," "healing," "improved vascular and cellular structural integrity," and treating various conditions including "wound care" and "bacterial infection." These claims lack safety and efficacy evidence, posing public health risks due to potential delays in definitive treatment.

The device is also adulterated under Quality System (QS) regulation (21 CFR Part 820) for: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), including undocumented design inputs, outputs, and inadequate design verification. 2. Failure to establish and maintain procedures for incoming product acceptance (21 CFR 820.80(b)) and maintain records of these activities. 3. Failure to establish and maintain procedures for purchasing controls (21 CFR 820.5