FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
K Number: K134040
·
Decision Sep 10, 2014
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
32
Applicant Total
3
Review Days
253
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Basic Information
- Device Name
- BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
- K Number
- K134040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Btl Industries, Ltd.
- Date Received
- December 31, 2013
- Decision Date
- September 10, 2014
- Product Code
- OLI
- 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 |
|---|---|---|---|
| OLI | Fat Reducing Low Level Laser | FDA class 2 | General, Plastic Surgery |
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