ONE · Class II · 21 CFR 878.4810

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 Philips Electronics Nederland B.V., iSMART Developments, Ltd. and Verilux.

7
Total
7
Cleared
230d
Avg days
2010
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 81d recently vs 255d historically

FDA 510(k) Cleared Powered Light Based Non-laser Surgical Instrument Devices (Product Code ONE)

7 devices
1–7 of 7
Cleared Apr 18, 2025
handLITE (TN19S)
K250224
iSMART Developments, Ltd.
General & Plastic Surgery · 81d
Cleared Jul 06, 2017
Philips BlueControl
K171055
Philips Electronics Nederland B.V.
General & Plastic Surgery · 87d
Cleared Jan 03, 2011
TANDA MAX
K103415
Pharos Life Corporation
General & Plastic Surgery · 42d
Cleared Nov 24, 2010
PLASMALUXLS
K100628
Daavlin Distributing Co.
General & Plastic Surgery · 264d
Cleared Sep 17, 2010
BABY QUASAR
K091467
Silver Bay, LLC
General & Plastic Surgery · 487d
Cleared Sep 03, 2010
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
K091125
Verilux
General & Plastic Surgery · 504d
Cleared Feb 04, 2010
ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
K092800
Led Intellectual Properties, LLC
General & Plastic Surgery · 146d

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 510(k) Review Time - ONE Product Code

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 →