510(k) K081994
K081994 is an FDA 510(k) premarket notification submitted by Orthomerica Products, Inc. for the device "STARLIGHT". The FDA issued a decision of Substantially Equivalent on September 12, 2008. The device falls under product code OAN (Orthosis, Cranial, Laser Scan), a Class II device regulated under 21 CFR 882.5970. Orthomerica Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2008
- Date Received
- July 14, 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.