Company ยท US
Theradome, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2018. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OAP | Laser, Comb, Hair | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2018 | K180460 | Theradome LH40 Theradome, Inc. | OAP |
| Jan 9, 2018 | K171775 | Theradome LH80 PRO Theradome, Inc. | OAP |
| May 12, 2016 | K161046 | Laser Helmet LH40-EVO Theradome, Inc. | OAP |
| Jun 14, 2013 | K122950 | LASER HELMET Theradome, Inc. | OAP |
| Mar 2, 2012 | K113097 | LASER HELMET Theradome, Inc. | OAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||