Powered Light Based Non-laser Surgical Instrument With Thermal Effect

Product Code: ONF

General & Plastic Surgery General Optical Products / Medical

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 D

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 ONF

5816Powered Light Based Non-laser Surgical Instrument With Thermal EffectLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5816Powered Light Based Non-laser Surgical Instrument With Thermal EffectLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

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

Pre-market Notifications for ONF

K221214Hand-held IPL Device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200Shenzhen IONKA Medical Technology Co., Ltd.
K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.
K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products Ltd.
K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.
K210119IPL Hair Removal Device (Model: KCA423)Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd
K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.
K200616E>EyeCE-SWIN
K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.
K193072Lucent : IPLLUVO Medical Technologies, Inc.
K192519Multi-modality WorkstationBeijing Superlaser Technology Co., Ltd.
K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.
K181868SHINY RPL SystemIDS, Ltd.
K181298Harmony XL Multi-Application PlatformAlma Lasers Inc.
K161565DUOSTETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD
K161286IPL Therapy MachineBEIJING ADSS DEVELOPMENT CO., LTD

Global Unique Device Identification Database

00816995020554Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020516Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020509Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020486Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020479Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020462Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020448Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020431Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020424Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020400Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020394Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020370Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020363Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020349Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
00816995020332Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Maude Adverse Events

VENUS VERSA SYSTEMVENUS CONCEPT LTD.2019-08-08
ILIGHT IPL6500SHASER INC2019-06-26
ILIGHT IPL6750SHASER, INC.2018-09-18
IPL HAIRE REMOVERUNK2017-10-12
SCITON LASER SYSTEMSCITON INC.2017-05-05
ILIGHT PRO PLUS QUARTZSHASER INC2016-11-02
I-LIGHT PROSHASER INC2016-10-28
ILIGHT ULTRA FACE AND BODYSHASER INC2016-10-28
ILIGHT PRO PLUS QUARTZSHASER INC2016-09-29
I-LIGHT PRO IPL6500SHASER INC2016-08-25
ILIGHT PRO IPL6000SHASER INC2016-05-20
ILIGHT PRO IPL6000SHASER INC2015-10-09
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEMSOLTA MEDICAL2015-07-31
LUMARXSHASER, INC2015-04-10
LUMARXSHASER, INC2015-04-10
STRATAPULE PORTABLESHANGHAI APOLO MEDICAL TECH CO LTD.2014-09-15
STRATAPULSESHANGHAI APOLO MEDICAL TECH CO LTD2014-07-15

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