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., Solta Medical, Inc. and Palomar Medical Products, Inc..

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
Cleared Jul 06, 2017
CO2 Laser Therapy Systems
K162398
Beijing Sincoheren Science and Technology Development Co.
General & Plastic Surgery · 314d
Cleared Dec 30, 2014
TRIA FANP
K141868
Tria Beauty, Inc.
General & Plastic Surgery · 173d
Cleared Dec 24, 2014
MIDI-SRS
K141046
Srmc Co., Ltd.
General & Plastic Surgery · 245d
Cleared Oct 25, 2013
TRIA FAN SYSTEM
K130459
Tria Beauty, Inc.
General & Plastic Surgery · 245d
Cleared Sep 19, 2013
EQUINOX CO2 LASER
K131903
Eclipse Aesthetics, LLC
General & Plastic Surgery · 86d
Cleared Sep 03, 2013
RESURFX 1565NM LASER MODULE
K130028
Lumenis, Ltd.
General & Plastic Surgery · 243d
Cleared Apr 12, 2012
NATURALASE CO2 LASER SYSTEM
K110333
Focus Medical, LLC
General & Plastic Surgery · 434d
Cleared Apr 02, 2012
CLEAR + BRILLIANT LASER SYSTEM
K120433
Solta Medical, Inc.
General & Plastic Surgery · 49d
Cleared Dec 19, 2011
MX-7000 MICROXEL
K111831
Bio-Med USA, Inc.
General & Plastic Surgery · 174d
Cleared Nov 14, 2011
EMERGE FRACTIONAL LASER
K111840
Palomar Medical Products, Inc.
General & Plastic Surgery · 138d
Cleared Jul 22, 2011
SLIM E30 II CO2 LASER
K110984
Lasering S.R.L.
General & Plastic Surgery · 106d

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 →