Exhibit 99.1
December 19, 2019
SteriLumen, Inc
℅ Bryce Whited
VP Medical Devices & Combination Products
The Weinberg Group
1129 20th Street, NW, Suite 600
Washington, DC 20036
| Re: | C190089 |
Product Name: Disinfecting Mirror
Dated: December 12, 2019
Received: December 12, 2019
Dear Bryce Whited:
We have reviewed the above referenced request for information, submitted in accordance with Section 513(g) of the Federal Food, Drug, and Cosmetic Act (Act), regarding the regulatory requirements applicable to the Disinfecting Mirror. As described in your submission, we believe that your product is not a "device" as that term is defined in Section 201(h) of the Act. Therefore, you are not required to comply with the requirements of the Act. Please note, if you later revise your indications to add medical claims, you may need a premarket notification [510(k)] submission.
For comprehensive regulatory information about medical devices and radiation-emitting products, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
| C190089 - Bryce Whited | Page 2 |
If you have any questions regarding this letter, please contact Elizabeth Claverie, M.S. , Assistant Director, THT4B2, at 301-796-6298.
Sincerely, | |
| /s/ David Krause | |
| for | Binita Ashar, M.D., M.B.A., F.A.C.S. |
| Director | |
| OHT4: Office of Surgical | |
| and Infection Control Device | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
