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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered surgical instrument for improvement in the appearance of cellulite
Definition Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Product CodeOUP
Regulation Number 878.4790
Device Class 2


Premarket Reviews
ManufacturerDecision
NC8, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTHERA, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 7 7
2019 16 16
2020 3 3
2021 9 9
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23 23
Insufficient Information 7 7
Break 6 6
Decrease in Suction 2 2
Failure to Cut 1 1
Patient-Device Incompatibility 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Suction Failure 1 1
Physical Property Issue 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Scar Tissue 12 12
Deformity/ Disfigurement 9 9
No Known Impact Or Consequence To Patient 8 8
Laceration(s) 5 5
Pain 5 5
Bruise/Contusion 4 4
Edema 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Scarring 2 2
No Code Available 2 2
Swelling/ Edema 2 2
Impaired Healing 2 2
Distress 2 2
Reaction 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1
Device Embedded In Tissue or Plaque 1 1
Seroma 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Ulcer 1 1
Anxiety 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1
Burn(s) 1 1
Contusion 1 1

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