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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered laser surgical instrument with microbeam\fractional output
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Product CodeONG
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
AVAVA, INC
  SUBSTANTIALLY EQUIVALENT 1
AVAVA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LUTRONIC AESTHETIC
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WINGDERM ELECTRO-OPTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 9 9
2022 2 2
2023 3 3
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Insufficient Information 10 10
Unexpected Shutdown 1 1
Firing Problem 1 1
Product Quality Problem 1 1
Key or Button Unresponsive/not Working 1 1
Energy Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 12 12
Burn(s) 10 10
Skin Discoloration 8 8
Swelling/ Edema 4 4
Blister 4 4
Partial thickness (Second Degree) Burn 4 4
Inflammation 2 2
Itching Sensation 2 2
Rash 2 2
Anxiety 2 2
Pain 2 2
Scar Tissue 2 2
Unspecified Infection 2 2
Depression 2 2
Anaphylactic Shock 1 1
Peeling 1 1
Ulceration 1 1
Discomfort 1 1
Skin Inflammation/ Irritation 1 1
Deformity/ Disfigurement 1 1
Irritation 1 1
Distress 1 1
Skin Infection 1 1
Skin Irritation 1 1
Swelling 1 1
Burning Sensation 1 1
Idioventricular Rhythm 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 IDS LTD II Jan-07-2025
2 WINGDERM ELECTRO-OPTICS LTD. II Dec-05-2024
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