FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
K Number: K142924
·
Decision Feb 13, 2015
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
128
Basic Information
- Device Name
- Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
- K Number
- K142924
- 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
- SHASER, INC.
- Date Received
- October 8, 2014
- Decision Date
- February 13, 2015
- 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 SHASER, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | May 27, 2015 | Substantially Equivalent |
| K141583 | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY | Jul 22, 2014 | Substantially Equivalent |
| K140631 | LUMENA FH HAIR REMOVAL SYSTEM | May 16, 2014 | Substantially Equivalent |
| K133201 | SHASER V-MINI 2 HAIR REMOVAL SYSTEM | Feb 12, 2014 | Substantially Equivalent |
| K132170 | SHASER V-MINI RX | Nov 26, 2013 | Substantially Equivalent |
| K132266 | SHASER HRS2 RX HAIR REMOVAL SYSTEM | Sep 30, 2013 | Substantially Equivalent |
| K130015 | SHASER V-MINI HAIR REMOVAL SYSTEM | Jun 13, 2013 | Substantially Equivalent |
| K120080 | SHASER HRS2 HAIR REMOVAL SYSTEM | May 25, 2012 | Substantially Equivalent |
| K103560 | SHASER IPL HAIR REMOVAL SYSTEM | May 18, 2011 | Substantially Equivalent |