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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, cranial, laser scan
Definition A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Product CodeOAN
Regulation Number 882.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSCULPTOR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOMERICA PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOMERICA PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K090587  STARLIGHT
  2.  K124023  STARBAND
  3.  K133250  STARLIGHT
  4.  K142141  STARBAND, STARLIGHT
  5.  K151147  STARband, STARlight
  6.  K151979  STARband, STARlight
  7.  K161138  St. Louis Band
ORTHOMERICA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 7
  1.  K090587  STARLIGHT
  2.  K124023  STARBAND
  3.  K133250  STARLIGHT
  4.  K142141  STARBAND, STARLIGHT
  5.  K151147  STARband, STARlight
  6.  K151979  STARband, STARlight
  7.  K161138  St. Louis Band

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 1 1
Skull Fracture 1 1

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