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CLOSEOUT LETTER

Laser Dental Innovations MARCS-CMS 546341 —

Delivery Method:
UPS Overnight
Product:
Medical Devices

Recipient:
Recipient Name
Howard A. Feinberg
Recipient Title
President
Laser Dental Innovations

1219 Quail Creek Circle
San Jose, CA 95120
United States

Issuing Office:
Center for Devices and Radiological Health

19701 Fairchild
Irvine, CA 92612
United States


Dear Mr. Feinberg:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated February 27, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
For Bryan Love
Acting Director, Compliance Branch