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510(k) K211376

STARband by Orthomerica Products, Inc. — Product Code OAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2021
Date Received
May 4, 2021
Clearance Type
Special
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 by Orthomerica Products, Inc.

  • K240466 — STARband 3D (March 15, 2024)
  • K223238 — STARband 3D (April 20, 2023)
  • 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)
  • K141842 — STARBAND, STARLIGHT (October 6, 2014)
  • K140353 — STARBAND AND STARLIGHT (June 6, 2014)

Other clearances for product code OAN

  • K244056 — DOC Band 3D (March 17, 2025)
  • K240466 — STARband 3D (March 15, 2024)
  • 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)
  • K124023 — STARBAND (June 10, 2013)