FDA Registration
Active
🇺🇸 United States
Hairmax LaserBand 82 ComfortFlex
Reg #: 3006182775
·
FEI: 3006182775
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- Lexington International LLC
- Registration Number
- 3006182775
- FEI Number
- 3006182775
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1040 HOLLAND DR
- City
- Boca Raton
- State
- FL
- ZIP
- 33487
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142573
Owner / Operator
- Firm Name
- LEXINGTON INTERNATIONAL, LLC
- Operator Number
- 9055586
- Address
- 1040 Holland Drive, --
- City
- Boca Raton
- State
- FL
- Postal Code
- 33487
- Country
- US
- Correspondent
- Jose - Robert
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2014-12-15 |
Proprietary Names
Hairmax LaserBand 82 ComfortFlex
HairMax LaserBand 82
Hairmax LaserBand 41 ComfortFlex
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device