FDA Product Code ONE: Powered Light Based Non-laser Surgical Instrument
A Light Based Non-laser Device Typically Indicated To Be Used For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. Indication For Use Can Be General And/or Specific. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
Leading manufacturers include iSMART Developments, Ltd..
FDA 510(k) Cleared Powered Light Based Non-laser Surgical Instrument Devices (Product Code ONE)
About Product Code ONE - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code ONE since 2010, with 7 receiving FDA clearance (average review time: 230 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ONE have taken an average of 81 days to reach a decision - down from 255 days historically, suggesting improved FDA processing for this classification.
ONE devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →