ONG · Class II · 21 CFR 878.4810

FDA Product Code ONG: Powered Laser Surgical Instrument With Microbeamfractional Output

A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. 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 Avava, Inc., Shanghai Apolo Medical Technology Co., Ltd. and Ids, Ltd..

35
Total
35
Cleared
168d
Avg days
2009
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg 117d recently vs 175d historically

FDA 510(k) Cleared Powered Laser Surgical Instrument With Microbeamfractional Output Devices (Product Code ONG)

35 devices
1–24 of 35
Cleared Oct 20, 2025
AVAVA™ Skin Treatment System
K252155
Avava, Inc.
General & Plastic Surgery · 103d
Cleared Jul 31, 2025
eCO2 3D
K244060
Lutronic Corporation
General & Plastic Surgery · 212d
Cleared Jul 02, 2025
Fiber Laser Treatment Systems (HS-232,HS-233)
K251031
Shanghai Apolo Medical Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 14, 2025
AVAVA™ Skin Treatment System
K250402
Avava, Inc.
General & Plastic Surgery · 61d
Cleared Jan 02, 2024
MOSAIC 3D (Surgical Laser)
K233550
Lutronic Aesthetic
General & Plastic Surgery · 60d
Cleared Jun 22, 2023
Miria Skin Treatment System
K223871
Avava, Inc.
General & Plastic Surgery · 181d
Cleared Nov 21, 2022
SR-1 Skin Treatment System
K221268
Avava, Inc.
General & Plastic Surgery · 203d
Cleared Oct 13, 2022
Fiber Laser Treatment System
K221770
Shanghai Apolo Medical Technology Co., Ltd.
General & Plastic Surgery · 114d
Cleared Jun 03, 2022
Multifrax Laser System
K213332
Paradigm Medical Corporation
General & Plastic Surgery · 240d
Cleared Apr 13, 2021
SR-1 Skin Treatment System
K202884
Avava, Inc.
General & Plastic Surgery · 197d
Cleared Apr 30, 2020
Medical Non-Ablative Fractional Laser Systems
K192350
Wingderm Electro-Optics , Ltd.
General & Plastic Surgery · 245d
Cleared Nov 30, 2018
Advanced Skin Renewing Device
K182498
Jiangsu Unimed Laser Technology Co., Ltd.
General & Plastic Surgery · 79d
Cleared Feb 02, 2018
SMAXEL CO2 Surgical Laser System
K180036
Ids, Ltd.
General & Plastic Surgery · 28d

About Product Code ONG - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code ONG since 2009, with 35 receiving FDA clearance (average review time: 168 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - ONG Product Code

Recent submissions under ONG have taken an average of 117 days to reach a decision - down from 175 days historically, suggesting improved FDA processing for this classification.

ONG devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →