Cleared Traditional

K081787 - CAMLAB CRANIAL ORTHOSIS HELMET

K081787 is an FDA 510(k) clearance for CAMLAB CRANIAL ORTHOSIS HELMET, manufactured by Biosculptor Corporation. The device is a Class 2 Neurology device with product code OAN cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K081787 · Biosculptor Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
217d
Days
Class 2
Risk

K081787 is an FDA 510(k) clearance for the CAMLAB CRANIAL ORTHOSIS HELMET. Classified as Orthosis, Cranial, Laser Scan (product code OAN), Class II - Special Controls.

Submitted by Biosculptor Corporation (Hialeah, US). The FDA issued a Cleared decision on January 27, 2009 after a review of 217 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosculptor Corporation devices

FDA 510(k) Submission Details - K081787

510(k) Number K081787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2008
Decision Date January 27, 2009
Days to Decision 217 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 148d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAN Device Classification - Class 2, Special Controls

Product Code OAN Orthosis, Cranial, Laser Scan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OAN Orthosis, Cranial, Laser Scan

All 18
Devices cleared under the same product code (OAN) and FDA review panel - the closest regulatory comparables to K081787.
STARLIGHT
K133250 · Orthomerica Products, Inc. · Jan 2014
STARBAND
K124023 · Orthomerica Products, Inc. · Jun 2013
STARLIGHT
K090587 · Orthomerica Products, Inc. · Jul 2009
STARBAND
K082950 · Orthomerica Products, Inc. · Dec 2008
STARLIGHT
K082945 · Orthomerica Products, Inc. · Oct 2008
STARLIGHT
K081994 · Orthomerica Products, Inc. · Sep 2008