BEUDAMED
    Product Code: ONF FDA class 2 21 CFR 878.4810

    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

    General, Plastic Surgery

    The Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (product code ONF) is a Class 2 surgical device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It provides thermal effects using broad-spectrum sources such as intense pulsed light (IPL) and is typically indicated for use in plastic surgery, general surgery, and dermatology/aesthetic specialties. The device is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    74
    FEI Numbers
    92
    Registration Numbers
    93
    Unique Applicants
    59
    Years Active
    18

    Research product code ONF in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    ONF
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. 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, or remove tissue by the light.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 74 510(k) clearances via K numbers.

    K Number Device Name
    K261204 Intense Pulsed Light Therapy Device
    K251545 Intense Pulsed Light Therapy Device (MMABM-1)
    K231952 MEDILIGHT
    K243123 IPL Treatment Device (MDSQMC-01)
    K250281 DEKA LOTUS
    K242440 Intense Pulsed Light Treatment System (LK-PT)
    K240314 MULA (K2-A1)
    K240482 Intense Pulsed Light System (ST-690)
    K233473 DEKA LOTUS
    K233307 Intensity Pulsed Light Therapy System
    K232708 Intense pulsed light therapy device
    K232192 Venus Versa PRO System
    K231394 Intense Pulsed Light System
    K230816 Intense Pulsed Light Treatment System
    K220214 Painless IPL System - KDT750
    K220794 10PL
    K221214 Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
    K220385 Intense Pulsed Light Equipment
    K213558 IPL Hair Removal Device
    K212907 Aimanfun Lumea Comfort, A-2789/A-3588
    K211368 IPL Hair Remover, Model: G993, G996, G998 and G885
    K212099 Red Wave Hair Removal
    K210119 IPL Hair Removal Device (Model: KCA423)
    K200616 E>EyeC
    K200746 IPL Treatment Systems
    K193328 IPL + Diode Laser Machine
    K193072 Lucent : IPL
    K192521 Intense Pulsed Light Treatment System
    K192519 Multi-modality workstation
    K181868 SHINY RPL System
    K181298 Harmony XL Multi-Application Platform
    K161565 DUO
    K161286 IPL Therapy Machine
    K160195 Forma System, Forma Light System
    K153717 Venus Versa System
    K152790 Venus Versa System
    K150282 Shaser Skin Beauty Intense Pulsed Light System Family for Acne
    K150051 Exilite
    K141237 HARMONY LITE
    K143339 Mini me
    K140668 PLATINUMGMT IPL SYSTEM CLOUD
    K140670 ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
    K141583 SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
    K131712 A-TONE IPL SYSTEM
    K140631 LUMENA FH HAIR REMOVAL SYSTEM
    K133201 SHASER V-MINI 2 HAIR REMOVAL SYSTEM
    K131649 ME
    K132170 SHASER V-MINI RX
    K131859 MULTIFUNCTIONAL SERIES
    K132266 SHASER HRS2 RX HAIR REMOVAL SYSTEM
    K130015 SHASER V-MINI HAIR REMOVAL SYSTEM
    K123860 INMODE SR IPL DEVICE
    K123889 ACLEARA, THERACLEAR
    K123435 IPL THERAPY SYSTEM
    K122995 INTENSE PULSED LIGHT (IPL) SYSTEMS
    K123845 ME
    K121598 ME HAIR2GO
    K121515 ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
    K120080 SHASER HRS2 HAIR REMOVAL SYSTEM
    K111350 MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM
    K103560 SHASER IPL HAIR REMOVAL SYSTEM
    K101901 IPL THERAPY SYSTEM
    K093627 IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
    K102857 AHWON'S IPL SYSTEM
    K093168 MEDIFLASH AND ESTEFLASH
    K100053 MATTIOLI PULSE TWO/THREE PLUS FAMILY
    K092326 SMOOTHCOOL
    K093465 FUSION SYSTEM
    K091664 GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
    K090724 OR-LIGHT
    K082040 MINISILK FT
    K090837 STRATAPULSE TS AND STRATAPULSE
    K090399 TRIOS SYSTEM
    K082484 ACCELAWAVE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.