Cleared Traditional

K200168 - Dermapose Access

K200168 is the FDA 510(k) clearance for Dermapose Access by Puregraft, LLC. It is a Class 2 General & Plastic Surgery device (product code QPB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K200168 · Puregraft, LLC · General & Plastic Surgery device
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Apr 2020
Decision
90d
Days
Class 2
Risk

K200168 is an FDA 510(k) clearance for the Dermapose Access. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Puregraft, LLC (Solana Beach, US). The FDA issued a Cleared decision on April 22, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Puregraft, LLC devices

Submission Details

510(k) Number K200168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2020
Decision Date April 22, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QPB System, Suction, Lipoplasty For Removal

All 18
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K200168.
PAL Infiltration System
K220318 · Microaire Surgical Instruments, LLC · Oct 2022
PAL System
K212024 · Microaire Surgical Instruments, LLC · Jun 2022
PAL Single-Use Cannulas
K192694 · Microaire Surgical Instruments · May 2020
VASERlipo System
K190551 · Solta Medical · May 2019
PowerX Lipo System
K190555 · Solta Medical · May 2019
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K004005 · Mentor Corp. · Oct 2001