FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRA HAIR REMOVAL LASER
K Number: K053527
·
Decision Feb 1, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
774
Basic Information
- Device Name
- SPECTRA HAIR REMOVAL LASER
- K Number
- K053527
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPECTRAGENICS, INC.
- Date Received
- December 19, 2005
- Decision Date
- February 1, 2008
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by SPECTRAGENICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K090820 | TRIA HAIR REMOVAL LASER SYSTEM | Dec 23, 2009 | Substantially Equivalent |
| K060567 | SPECTRAGENICS ATS-1 | Apr 28, 2006 | Substantially Equivalent |
| K052848 | SPECTRA HAIR REMOVAL LASER | Dec 27, 2005 | Substantially Equivalent |
| K032846 | SPECTRA PULSED DIODE LASER, MODEL DR-1 | Dec 11, 2003 | Substantially Equivalent |