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# CureWave Lasers Marketing Unapproved Device: FDA
- URL: https://www.fdaweb.com/curewave-lasers-marketing-unapproved-device-fda/
- Published: 2020-01-21T12:00:00.000Z
- Updated: 2026-09-14T15:59:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145883

An 8/22-9/5/19 FDA inspection at CureWave Lasers, Dallas. TX, found that the firm is manufacturing the CureWave Medicore without an approved PMA or IDE in place. A just-released 12/12/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curewave-lasers-llc-593692-12122019?ref=fdaweb.com) says the firm’s device is misbranded because the company did not notify FDA of its intent to introduce the device into commercial distribution.

According to the letter, the firm submitted a 5/18/17 premarket notification for the CureWave System, CureWave Laser, and CureWave Medicore and was advised by FDA 7/14/17 that the devices were classified as Class 2 exempt. FDA also said that if the company were to modify the device in the future by introducing either a new indication for use or a fundamental scientific technology different from that in the regulation, the device might exceed the limitations to the exemption and could require a 510(k) clearance prior to marketing.

According to FDA, the firm’s Web sites are promoting the device for claims that are not within the scope of the exemption from 510(k) notification. FDA says CureWave has provided no evidence supporting the safety and efficacy of its laser devices as marketed on its Web sites. “The lack of evidence demonstrating the safety and efficacy of these claims raises public health concerns,” it says. “Specifically, the risk for these devices, as advertised, is delay in definitive treatment. For example, delayed or ineffective treatment for wound care and bacterial infection can lead to loss of function, amputation, or death. Additionally, delayed or ineffective treatment for nerve damage can lead to permanent loss of function.”

The letter says the agency will evaluate the information the firm submits and decide whether the product may be legally marketed.

The inspection also found these Quality System Regulation violations: 

- failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
- failing to establish and maintain procedures for acceptance activities in incoming components or finished products;
- failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and regulatory requirements;
- failing to certify, based on a test, in accordance with the standard, the individual article to which the electronic product is attached, or upon a testing program that is in accordance with good manufacturing practices;
- failing to incorporate in each Class 4 medical laser product a means for measuring the level of that laser radiation intended for irradiation of the human body, having an error in measurement of no more than 20% when calibrated;
- failing to affix to each medical laser product, in close proximity to each aperture through which is emitted accessible laser radiation in excess of the accessible emission limits of Class 1, a label bearing the wording “laser aperture”; and
- failing to provide the full name and address of the product manufacturer in a label;
- failing to submit a product report to CDRH before the introduction of a laser product into commerce.

 FDA says it reviewed the company’s 9/26/19 response to the FDA-483 and found it was inadequate in that the company said a contractor would assist with the execution of corrective and preventive actions and implement a complete quality system but did not offer any details on proposed corrective actions, so the agency could not determine the effectiveness of the changes.

CureWave was told to respond with specific steps taken to correct the violations and prevent them from recurring, with documentation of the steps and a timetable for completion.