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510(k) K202443

Smart Kit Basic, Smart Kit Pro by Bsl Co., Ltd. — Product Code MUU

K202443 is an FDA 510(k) premarket notification submitted by Bsl Co., Ltd. for the device "Smart Kit Basic, Smart Kit Pro". The FDA issued a decision of Substantially Equivalent on March 11, 2021. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2021
Date Received
August 26, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

Other clearances for product code MUU

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  • K203800 — SyntrFuge System (July 2, 2021)
  • K193539 — REVOLVE ENVI 600 Advanced Adipose System (May 28, 2020)
  • K193363 — Dermapose Refresh (April 14, 2020)
  • K182732 — JTL-250-01 (November 18, 2019)
  • K191564 — Progenikine Concentrating System 25 mL System (November 7, 2019)
  • K190386 — KTA Adipose Treatment Kit (October 10, 2019)
  • K190278 — AuraGen 123 Suction Lipoplasty System (A123) (May 3, 2019)
  • K172717 — Automatic Tissue Processing Unit (May 25, 2018)
  • K172714 — LipiVage (December 8, 2017)

FDA data resources