Powered Light Based Non-laser Surgical Instrument

Product Code: ONE

General & Plastic Surgery General Optical Products / Medical

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 C

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as ONE

5815Powered Light Based Non-laser Surgical InstrumentLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5815Powered Light Based Non-laser Surgical InstrumentLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Powered Light Based Non-Laser Surgical Instrument [30278]21 CFR §878.4810 🔎
Powered Light Based Non-Laser Surgical Instrument [38651]21 CFR §878.4810 🔎
Powered Light Based Non-Laser Surgical Instrument [38649]21 CFR §878.4810 🔎
Powered Light Based Non-Laser Surgical Instrument [38650]21 CFR §878.4810 🔎
Powered Light Based Non-Laser Surgical Instrument [34006]21 CFR §878.4810 🔎
Powered Light Based Non-Laser Surgical Instrument [29958]21 CFR §878.4810 🔎

Pre-market Notifications for ONE

K171055Philips BlueControlPhilips Electronics Nederland B.V.
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K100628PLASMALUXLSDAAVLIN DISTRIBUTING CO.
K092800ANTI-WRINKLE (AGING) LIGHT, MODEL AALLED INTELLECTUAL PROPERTIES, LLC
K091467BABY QUASARSILVER BAY, LLC
K091125CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2VERILUX

Global Unique Device Identification Database

00860564000317Powered Light Based Non-Laser Surgical Instrument
10841305111698Powered light based non-laser surgical instrument
10841305111520Powered light based non-laser surgical instrument
10841305111513Powered light based non-laser surgical instrument
10841305111506Powered light based non-laser surgical instrument
10841305111490Powered light based non-laser surgical instrument
10841305111483Powered light based non-laser surgical instrument
10841305111087Powered light based non-laser surgical instrument
10841305109916Powered light based non-laser surgical instrument
10841305106144Powered light based non-laser surgical instrument
10841305105567Powered light based non-laser surgical instrument
10841305105338Powered light based non-laser surgical instrument
10841305105192Powered light based non-laser surgical instrument

Maude Adverse Events

ANTI - WRINKLE LIGHTUNK2018-05-29
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