Orthosis, Cranial, Laser Scan

Product Code: OAN

Neurology Medical Laser Products

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 Po

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 882.5970


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OAN

3759Orthosis, Cranial, Laser ScanCranial Orthosis.

Total Product Life Cycle (TPLC) Devices

3759Orthosis, Cranial, Laser ScanCranial Orthosis.

Pre-market Notifications for OAN

K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc
K161138St. Louis BandORTHOMERICA PRODUCTS, INC.
K151979STARband, STARlightORTHOMERICA PRODUCTS, INC.
K151147STARband, STARlightORTHOMERICA PRODUCTS, INC.
K142141STARBAND, STARLIGHTORTHOMERICA PRODUCTS, INC.
K133250STARLIGHTORTHOMERICA PRODUCTS, INC.
K124023STARBANDORTHOMERICA PRODUCTS, INC.
K090587STARLIGHTORTHOMERICA PRODUCTS, INC.
K082950STARBANDORTHOMERICA PRODUCTS, INC.
K082945STARLIGHTORTHOMERICA PRODUCTS, INC.
K081994STARLIGHTORTHOMERICA PRODUCTS, INC.
K081787CAMLAB CRANIAL ORTHOSIS HELMETBIOSCULPTOR CORPORATION
K072862BOSTON-BAND CRANIAL REMODLING ORTHOSISBOSTON BRACE INTL., INC.
K072566HANGER CRANIAL BANDHANGER PROSTHETICS & ORTHOTICS, INC.
K063098STATIC CRANIOPLASTY ORTHOSISBOSTON BRACE INTL., INC.

Global Unique Device Identification Database

00862948000302Orthosis, Cranial, Laser Scan
B151765PA0Orthosis, Cranial, Laser Scan
B151765A0Orthosis, Cranial, Laser Scan
B15176507PA0Orthosis, Cranial, Laser Scan
B15176506PA0Orthosis, Cranial, Laser Scan
B15176506A0Orthosis, Cranial, Laser Scan
B15176503PA0Orthosis, Cranial, Laser Scan
B15176503A0Orthosis, Cranial, Laser Scan
B15176501PA0Orthosis, Cranial, Laser Scan
B15176501A0Orthosis, Cranial, Laser Scan
B151763PA0Orthosis, Cranial, Laser Scan
B151763A0Orthosis, Cranial, Laser Scan
B15176308A0Orthosis, Cranial, Laser Scan
B15176307PA0Orthosis, Cranial, Laser Scan
B15176306PA0Orthosis, Cranial, Laser Scan
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