510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081787Substantially Equivalent

Camlab Cranial Orthosis Helmet

Biosculptor Corporation, Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081787 is the FDA 510(k) clearance record for CAMLAB CRANIAL ORTHOSIS HELMET, a class II device, cleared for Biosculptor Corporation on under FDA product code OAN (Orthosis, Cranial, Laser Scan). FDA's definition for product code OAN reads: "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...". FDA records list one 510(k) clearance for Biosculptor Corporation. As of , FDA records show no recalls naming K081787.

Clearance record

Decision date
Received
(217 days to decision)
Product code
OAN Orthosis, Cranial, Laser Scan
Regulation
21 CFR 882.5970
Device class
Class II
Review panel
Neurology
Applicant
Biosculptor Corporation 2480 W. 82nd St. #8, Hialeah FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAN

Trailing 12 months

FDA records hold no clearances under product code OAN in the trailing twelve months.

FDA records show no clearances under product code OAN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OAN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260