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510(k) K242532

BTL-785BNF-E by BTL Industries, Inc. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2024
Date Received
August 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by BTL Industries, Inc.

  • K252561 — BTL-754FF (February 18, 2026)
  • K250309 — BTL-199 (August 7, 2025)
  • K243290 — BTL-785MJ (May 9, 2025)
  • K241516 — BTL-398 (February 10, 2025)
  • K241270 — BTL-754 (January 30, 2025)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233849 — BTL-499 (April 23, 2024)
  • K233604 — BTL-785S (March 28, 2024)
  • K230657 — BTL-99-OC (February 1, 2024)
  • K232937 — BTL-899M (December 26, 2023)

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  • K251909 — NeurotriS (SX2500); NeurotriS (SX3800) (September 3, 2025)
  • K252218 — MF SC GEN2 Facial Toning System (July 18, 2025)
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