FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
K Number: K083915
·
Decision Jan 29, 2009
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
30
Basic Information
- Device Name
- ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
- K Number
- K083915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ADVANCED TECHNOLOGY LASER CO., LTD.
- Date Received
- December 30, 2008
- Decision Date
- January 29, 2009
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 ADVANCED TECHNOLOGY LASER CO., LTD.
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|---|---|---|---|
| K140249 | LONG PULSE ND: YAG LASER SYSTEM | Oct 8, 2014 | Substantially Equivalent |
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