Product Code: OAN FDA class 2 21 CFR 882.5970

Orthosis, Cranial, Laser Scan

Neurology

The Orthosis, Cranial, Laser Scan (product code OAN) is a cranial remolding orthosis that uses laser scanning technology to create a customized fit, applying gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry and shape, indicated for infants aged 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 882.5970 within the Neurology specialty. The device carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

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Basic Information

Product Code: OAN
Device Class: FDA class 2
Regulation Number: 882.5970
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K244056	DOC Band 3D	Mar 17, 2025	Substantially Equivalent	Cranial Technologies, Inc.
K240466	STARband 3D	Mar 15, 2024	Substantially Equivalent	Orthomerica Products, Inc.
K211376	STARband	Aug 17, 2021	Substantially Equivalent	Orthomerica Products, Inc.
K203098	STARband, STARlight, St. Louis Band	Apr 27, 2021	Substantially Equivalent	Orthomerica Products, Inc.
K180109	STARband, STARlight, St. Louis Band	Mar 01, 2018	Substantially Equivalent	Orthomerica Products, Inc.
K161138	St. Louis Band	Jul 20, 2016	Substantially Equivalent	Orthomerica Products, Inc.
K151979	STARband, STARlight	Sep 18, 2015	Substantially Equivalent	Orthomerica Products, Inc.
K151147	STARband, STARlight	Jul 01, 2015	Substantially Equivalent	Orthomerica Products, Inc.
K142141	STARBAND, STARLIGHT	Apr 23, 2015	Substantially Equivalent	Orthomerica Products, Inc.
K133250	STARLIGHT	Jan 16, 2014	Substantially Equivalent	Orthomerica Products, Inc.
K124023	STARBAND	Jun 10, 2013	Substantially Equivalent	Orthomerica Products, Inc.
K090587	STARLIGHT	Jul 17, 2009	Substantially Equivalent	Orthomerica Products, Inc.
K081787	CAMLAB CRANIAL ORTHOSIS HELMET	Jan 27, 2009	Substantially Equivalent	Biosculptor Corporation
K082950	STARBAND	Dec 05, 2008	Substantially Equivalent	Orthomerica Products, Inc.
K082945	STARLIGHT	Oct 31, 2008	Substantially Equivalent	Orthomerica Products, Inc.
K081994	STARLIGHT	Sep 12, 2008	Substantially Equivalent	Orthomerica Products, Inc.
K072862	BOSTON-BAND CRANIAL REMODLING ORTHOSIS	Jan 22, 2008	Substantially Equivalent	Boston Brace Intl., Inc.
K072566	HANGER CRANIAL BAND	Jan 09, 2008	Substantially Equivalent	Hanger Prosthetics & Orthotics, Inc.
K063098	STATIC CRANIOPLASTY ORTHOSIS	Apr 11, 2007	Substantially Equivalent	Boston Brace Intl., Inc.
K021918	CLARREN HELMET (ORTHOMERICA)	Jul 25, 2002	Substantially Equivalent	Orthomerica Products, Inc.
K021207	STARLIGHT	Jul 09, 2002	Substantially Equivalent	Orthomerica Products, Inc.
K014012	DOC BAND	Jan 28, 2002	Substantially Equivalent	Cranial Technologies, Inc.
K011350	STARBAND CRANIAL ORTHOSIS	Jul 03, 2001	Substantially Equivalent	Orthomerica Products, Inc.