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510(k) K081787

CAMLAB CRANIAL ORTHOSIS HELMET by Biosculptor Corporation — Product Code OAN

K081787 is an FDA 510(k) premarket notification submitted by Biosculptor Corporation for the device "CAMLAB CRANIAL ORTHOSIS HELMET". The FDA issued a decision of Substantially Equivalent on January 27, 2009. The device falls under product code OAN (Orthosis, Cranial, Laser Scan), a Class II device regulated under 21 CFR 882.5970.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2009
Date Received
June 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cranial, Laser Scan
Device Class
Class II
Regulation Number
882.5970
Review Panel
NE
Submission Type

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.

Other clearances for product code OAN

  • K244056 — DOC Band 3D (March 17, 2025)
  • K240466 — STARband 3D (March 15, 2024)
  • K211376 — STARband (August 17, 2021)
  • K203098 — STARband, STARlight, St. Louis Band (April 27, 2021)
  • K180109 — STARband, STARlight, St. Louis Band (March 1, 2018)
  • K161138 — St. Louis Band (July 20, 2016)
  • K151979 — STARband, STARlight (September 18, 2015)
  • K151147 — STARband, STARlight (July 1, 2015)
  • K142141 — STARBAND, STARLIGHT (April 23, 2015)
  • K133250 — STARLIGHT (January 16, 2014)

FDA data resources