Data / Medical devices / United States / Theradome, Inc.
Theradome, Inc.: FDA-registered device maker in Wilmington, DE, United States, 2 510(k) clearances
Theradome, Inc. is registered with the FDA (registration 3008295459) in Wilmington, DE, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008295459
- Address
- 1000 N West St Ste 1200, Wilmington, DE, United States, 19801
- Owner or operator
- Theradome, Inc. (10048971)
- Roles
- Specification developer
- First device listed
- March 26, 2015
- Registered through
- 2026
- Brand names listed
- EVO LH40, PRO LH80
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2016 | K161046 | Laser Helmet LH40-EVO | OAP | Substantially Equivalent | Theradome, Inc. | accessdata.fda.gov |
| June 14, 2013 | K122950 | LASER HELMET | OAP | Substantially Equivalent | Theradome, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 12, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.