Medical Device Manufacturer · US , Malborough , MA

BTL Industries, Inc. - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 2010
41
Total
41
Cleared
0
Denied

FDA 510(k) cleared devices by BTL Industries, Inc. General & Plastic Surgery

20 devices
1-20 of 20
Cleared Mar 17, 2026
BTL-785NEH
K253750 · GEI
General & Plastic Surgery · 112d
Cleared Feb 18, 2026
BTL-754FF
K252561 · GEX
General & Plastic Surgery · 189d
Cleared Jan 30, 2025
BTL-754
K241270 · GEX
General & Plastic Surgery · 269d
Cleared Apr 23, 2024
BTL-499
K233849 · GEI
General & Plastic Surgery · 140d
Cleared Mar 28, 2024
BTL-785S
K233604 · GEI
General & Plastic Surgery · 140d
Cleared Sep 21, 2023
BTL-899F
K230467 · GEI
General & Plastic Surgery · 212d
Cleared May 31, 2023
BTL-785X
K222556 · GEI
General & Plastic Surgery · 281d
Cleared Mar 07, 2022
BTL-785W
K211639 · GEI
General & Plastic Surgery · 284d
Cleared Jan 05, 2022
BTL-899A
K213344 · GEI
General & Plastic Surgery · 90d
Cleared Jul 09, 2021
BTL-899 FP
K211107 · GEI
General & Plastic Surgery · 86d
Cleared Mar 29, 2019
BTL-084
K190023 · PBX
General & Plastic Surgery · 84d
Cleared Dec 13, 2018
BTL-FR2000
K180359 · GEI
General & Plastic Surgery · 307d
Cleared Jan 12, 2017
Exilis XP II
K163176 · PBX
General & Plastic Surgery · 59d
Cleared Sep 13, 2016
TR-100
K161551 · PBX
General & Plastic Surgery · 102d
Cleared Jul 20, 2016
XP1100 RF
K152731 · GEI
General & Plastic Surgery · 302d
Cleared Sep 16, 2015
XP3000
K150720 · PBX
General & Plastic Surgery · 181d
Cleared Jun 11, 2015
XP1000 RF
K143559 · GEI
General & Plastic Surgery · 177d
Cleared Apr 08, 2015
Exilite
K150051 · ONF
General & Plastic Surgery · 86d
Cleared Mar 06, 2015
XP300
K143109 · GEI
General & Plastic Surgery · 128d
Cleared Jan 15, 2015
Exilis XP
K143040 · PBX
General & Plastic Surgery · 85d
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