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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, comb, hair
Definition Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Product CodeOAP
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVIHAIR S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
AUXO HAIR, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOPHOTAS INC
  SUBSTANTIALLY EQUIVALENT 1
CAPILLUS
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONVERSION LABS, PR, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN LESCOLTON INTELLIGENT ELECTRICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN LESCOLTON MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FREEDOM LASER THERAPY, INC.
  SUBSTANTIALLY EQUIVALENT 3
HUBEI YJT TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
KAM YUEN PLASTIC PRODUCTS LTD
  SUBSTANTIALLY EQUIVALENT 1
KAM YUEN PLASTIC PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
KUNSHAN BELLA OPTICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEANA ORDERS, INC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHT TREE VENTURES EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 2
LUMENIS BE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NATURE INCREDIBLE INC
  SUBSTANTIALLY EQUIVALENT 2
OMM IMPORTS, INC. D/B/A ZERO GRAVITY
  SUBSTANTIALLY EQUIVALENT 1
PJM WORLDWIDE, LLC D/B/A PHOENIX MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANG FA BIOTECHNOLOGY CO.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COSBEAUTY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SLINPH TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
TRANSDERMAL CAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
WON TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
WONTECH
  SUBSTANTIALLY EQUIVALENT 1
XTRALLUX, LLC
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
Y&J BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YIBIN YINGTONG INTELLIGENT TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Product Quality Problem 2 2
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hair Loss 4 4
Headache 3 3
Radiation Exposure, Unintended 3 3
Itching Sensation 2 2
Pain 1 1
Cyst(s) 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 OMM Imports, Inc. dba Zero Gravity II Mar-14-2023
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