BTL-9000; BTL-9000 Radiofrequency Module
FDA 510(k) K134040 · Btl Industries, Ltd.
510(k) numberK134040
Submission
- Device name
- BTL-9000; BTL-9000 Radiofrequency Module
- Applicant
- Btl Industries, Ltd.
Waltham, MA, US - Received
- December 31, 2013
- Decision date
- September 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLI – Fat Reducing Low Level Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5400
- Specialty
- General, Plastic Surgery
Non-invasive reduction in fat layer for body contouring
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Questions and answers
When was BTL-9000; BTL-9000 Radiofrequency Module cleared by the FDA?
BTL-9000; BTL-9000 Radiofrequency Module (K134040) received a 510(k) decision of Substantially Equivalent on September 10, 2014, 253 days after the submission was received.
What is the product code of K134040?
The FDA product code is OLI – Fat Reducing Low Level Laser, a Class II (moderate risk) device regulated under 21 CFR 878.5400.