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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
Regulation Description Infrared lamp.
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
ALMA LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APIRA SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXO HAIR, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOPHOTAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COSMO FAR EAST TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN LESCOLTON INTELLIGENT ELECTRICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN LESCOLTON MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TUTAMEN METALWORK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOREO, INC.
  SUBSTANTIALLY EQUIVALENT 1
FREEDOM LASER THERAPY, INC.
  SUBSTANTIALLY EQUIVALENT 2
HUBEI YJT TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
KAM YUEN PLASTIC PRODUCTS , LTD.
  SUBSTANTIALLY EQUIVALENT 2
LEANA ORDERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHT TREE VENTURES EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 3
LUMENIS BE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NATURE, INC.REDIBLE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLM WORLDWIDE, LLC D/B/A PHOENIX MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
REVIAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BREO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHUANGHONG ZHILIAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COSBEAUTY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IDEA LIGHT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN NUON MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEBRANDS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSDERMAL CAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
WONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XTRALLUX, LLC
  SUBSTANTIALLY EQUIVALENT 1
YIBIN YINGTONG INTELLIGENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZDEER TECHNOLOGY (HENAN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIREE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 2 2
2024 1 1
2025 11 11
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 8 8
Excessive Heating 3 3
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Headache 6 6
Hair Loss 3 3
Erythema 2 2
Hypersensitivity/Allergic reaction 1 1
Cyst(s) 1 1
Itching Sensation 1 1
Burn(s) 1 1
Rash 1 1
Discomfort 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Pain 1 1

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