QUALITY
Spectra Medical Devices, LLC Quality Commitment:
- Provide safe and effective products that satisfy our customer’s needs
- Maintain Product Quality and Safety “built in” and not “tested in”
- Continually review and improve the effectiveness of the QMS
- Ensure compliance to all applicable regulations
- We deliver this through aligned objectives, teamwork and open communication
fda registration #:
1224960
MASSACHUSETTS, U.S.A.
Cert # 0124793
Expiration 5 Jun 2025
SOUTH KOREA
Cert# SCC-0074-6
Expiration 28 Feb 2025
US & Korea Sites are 13485 ISO Certified
Spectra Medical Operates a Class 8 Clean Room
Electronic Instructions for Use:
For previous revisions of IFUs, contact Customer Service at customerservice@
Electronic Instructions for Use: