FDA.reportPublic FDA data

510(k) K203098

Device
STARband, STARlight, St. Louis Band
Applicant
Orthomerica Products, Inc.
510(k) number
K203098
Product code
OAN
Decision
Substantially Equivalent (SESE)
Decision date
2021-04-27
Date received
2020-10-14
Regulation
882.5970
Classification name
Orthosis, Cranial, Laser Scan
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David C. Kerr
Address
6333 N. Orange Blossom Trl. Orlando FL US 32810 32810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OAN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K244056DOC Band 3DCranial Technologies, Inc.2025-03-17
K240466STARband 3DOrthomerica Products, Inc.2024-03-15
K211376STARbandOrthomerica Products, Inc.2021-08-17
K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.2018-03-01
K161138St. Louis BandOrthomerica Products, Inc.2016-07-20
K151979STARband, STARlightOrthomerica Products, Inc.2015-09-18
K151147STARband, STARlightOrthomerica Products, Inc.2015-07-01
K142141STARBAND, STARLIGHTOrthomerica Products, Inc.2015-04-23
K133250STARLIGHTOrthomerica Products, Inc.2014-01-16
K124023STARBANDOrthomerica Products, Inc.2013-06-10
K090587STARLIGHTOrthomerica Products, Inc.2009-07-17
K081787CAMLAB CRANIAL ORTHOSIS HELMETBiosculptor Corporation2009-01-27
K082950STARBANDOrthomerica Products, Inc.2008-12-05
K082945STARLIGHTOrthomerica Products, Inc.2008-10-31
K081994STARLIGHTOrthomerica Products, Inc.2008-09-12