Identity
- Trade Name
- EVO LH40 FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- Theradome EVO LH40 laser helmet is a low level laser therapy (LLLT) devices containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp. FDA UDI
- Model / Reference
- EVO LH40 FDA UDI
- Description
- Theradome EVO LH40 laser helmet is a low level laser therapy (LLLT) devices containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp. FDA UDI
Identifiers
- Catalog Number
- EVO LH40 FDA UDI
- Primary DI / UDI-DI
- B399EVO0400 FDA UDI
- 510(k) Number
- K161046 FDA UDI
- FDA Product Code
- OAP FDA UDI
- GMDN Term
- Hair growth laser device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hair growth laser device
Evo Lh40 by Theradome, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HairMax — Lexington International, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Theradome, Inc.
Sources (1)
- FDA UDI b9abeac2-9abc-41d7-a5e3-5a96ed8be27a 37 fields · synced Jun 6, 2026