510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K134040Substantially Equivalent

Btl-9000; Btl-9000 Radiofrequency Module

BTL Industries, Inc, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K134040 is the FDA 510(k) clearance record for BTL-9000; BTL-9000 RADIOFREQUENCY MODULE, a class II device, cleared for Btl Industries, Ltd. on under FDA product code OLI (Fat Reducing Low Level Laser). FDA's definition for product code OLI reads: "Non-invasive reduction in fat layer for body contouring". FDA records list 45 510(k) clearances for Btl Industries, Ltd., from to . As of , FDA records show no recalls naming K134040.

Clearance record

Decision date
Received
(253 days to decision)
Product code
OLI Fat Reducing Low Level Laser
Regulation
21 CFR 878.5400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Btl Industries, Ltd. 16 Appleton St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLI

Trailing 12 months
5 clearances under product code OLI in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OLI, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260