Owlet’s Baby Sock and Laser Pediatric Port Wine Stains Get FDA Clearances

The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval.

The BabySat, manufactured by Owlet, is a wire-free sock-type device that uses pulse-oximetry technology to provide a real-time display of an infant’s heart rate and oxygen saturation level, alerting parents when these readings fall outside of the prescribed range.

The company previously received a warning letter from the FDA in October 2021 for marketing Owlet Smart Socks without 510(k) clearance. The letter instructed Owlet to cease “commercial distribution of the device,” and to apply for approval or clearance of the device.

Another device, Candela’s Vbeam 595 nm Pulsed Dye Laser, expanded its FDA cleared indications to include pediatric patients, birth to 21 years, for treatment of port wine stains (PWS) and infantile hemangiomas.

The device was used on more than 6,000 pediatric patients with PWS/hemangiomas in 33 peer-reviewed published studies. Treatment during infancy can be done without general anesthesia.

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