Theradome LH40
FDA 510(k) K180460 · Theradome, Inc.
510(k) numberK180460
Submission
- Device name
- Theradome LH40
- Applicant
- Theradome, Inc.
Pleasanton, CA, US - Received
- February 20, 2018
- Decision date
- May 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
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Questions and answers
When was Theradome LH40 cleared by the FDA?
Theradome LH40 (K180460) received a 510(k) decision of Substantially Equivalent on May 18, 2018, 87 days after the submission was received.
What is the product code of K180460?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.