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510(k) K193363

Dermapose Refresh by Puregraft, LLC — Product Code MUU

K193363 is an FDA 510(k) premarket notification submitted by Puregraft, LLC for the device "Dermapose Refresh". The FDA issued a decision of Substantially Equivalent on April 14, 2020. The device falls under product code MUU (System, Suction, Lipoplasty), a Class II device regulated under 21 CFR 878.5040. Puregraft, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2020
Date Received
December 4, 2019
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 by Puregraft, LLC

  • K200168 — Dermapose Access (April 22, 2020)

Other clearances for product code MUU

  • K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Bod (March 16, 2022)
  • K203800 — SyntrFuge System (July 2, 2021)
  • K202443 — Smart Kit Basic, Smart Kit Pro (March 11, 2021)
  • K193539 — REVOLVE ENVI 600 Advanced Adipose System (May 28, 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