FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAIRMAX LASERCOMB
K Number: K093499
·
Decision Nov 23, 2009
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
8
Review Days
11
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Basic Information
- Device Name
- HAIRMAX LASERCOMB
- K Number
- K093499
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lexington International, LLC
- Date Received
- November 12, 2009
- Decision Date
- November 23, 2009
- Product Code
- OAP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAP | Laser, Comb, Hair | FDA class 2 | Physical Medicine |
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Other Clearances by Lexington International, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K180885 | HairMax Laser | Jun 20, 2018 | Substantially Equivalent |
| K142573 | HairMax LaserComb, HairMax LaserComb | Dec 1, 2014 | Substantially Equivalent |
| K112524 | HAIRMAX LASERCOMB | Sep 26, 2011 | Substantially Equivalent |
| K111714 | HAIRMAX DUAL 12 | Aug 16, 2011 | Substantially Equivalent |
| K110233 | HAIRMAX LASERCOMB | May 27, 2011 | Substantially Equivalent |
| K103368 | HAIRMAX LASERCOMB | Apr 6, 2011 | Substantially Equivalent |
| K060305 | HAIRMAX LASERCOMB | Jan 18, 2007 | Substantially Equivalent |