# FDA WARNING_LETTER - Curewave Lasers LLC - September 05, 2019

Source: https://www.keypedia.com/records/warning_letter/curewave-lasers-llc/73514a46-6266-49de-88c1-06da78465dac

> FDA WARNING_LETTER for Curewave Lasers LLC on September 05, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Curewave Lasers LLC
- Inspection Date: 2019-09-05
- Product Type: Devices
- Office Name: Office of Medical Device and Radiological Health Operations (Division 1)
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/binita-s-ashar/5a2f78e1-1ad7-4bf2-b980-eb925e2c765e)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

Company: https://www.keypedia.com/companies/curewave-lasers-llc/c398e672-b95d-4b44-9571-eaf3718a2036

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations-division-1/c2b03748-4c7c-4f76-b2ea-bc8f47e6e7f2