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

Powered Light Based Non-Laser Surgical Instrument

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

ONE is the FDA product code for Powered Light Based Non-Laser Surgical Instrument, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "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...". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ONE
Device name
Powered Light Based Non-Laser Surgical Instrument
FDA definition
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.
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
7
Ingested recalls
0

Clearances, product code ONE

By decision year
7 clearances under product code ONE with a decision year between 2010 and 2025, 2010 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code ONE by decision year
YearClearances
20104
20111
20171
20251

Applicants with the most clearances

Product code ONE
Applicants holding the most 510(k) clearances under product code ONE
ApplicantClearances
The Daavlin Distributing Co.1
LED Intellectual Properties LLC1
Pharos Life Corporation1
Philips Electronics Nederland B.V.1
Silver Bay, LLC1
Verilux1
iSMART Developments, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code