FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKINSTATION
K Number: K030897
·
Decision Jun 19, 2003
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
11
Review Days
90
Basic Information
- Device Name
- SKINSTATION
- K Number
- K030897
- 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
- RADIANCY (ISRAEL) LTD.
- Date Received
- March 21, 2003
- Decision Date
- June 19, 2003
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K060411 | RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM | Mar 22, 2006 | Substantially Equivalent |
| K052991 | RADIANCY FACIAL SKINCARE DEVICE | Feb 1, 2006 | Substantially Equivalent |
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| K051671 | RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY | Sep 2, 2005 | Substantially Equivalent |
| K032205 | RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY | Dec 11, 2003 | Substantially Equivalent |
| K033181 | SPR SYSTEM | Oct 24, 2003 | Substantially Equivalent |
| K020856 | SPATOUCH PHOTOEPILATION SYSTEM | Jun 13, 2002 | Substantially Equivalent |