510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONGClass II

Powered Laser Surgical Instrument With MicrobeamFractional Output

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

ONG is the FDA product code for Powered Laser Surgical Instrument With MicrobeamFractional Output, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "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...". As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ONG
Device name
Powered Laser Surgical Instrument With MicrobeamFractional Output
FDA definition
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.
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
35
Ingested recalls
4

Clearances, product code ONG

By decision year
35 clearances under product code ONG with a decision year between 2009 and 2025, 2011 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code ONG by decision year
YearClearances
20094
20104
20116
20122
20133
20142
20171
20182
20201
20211
20223
20231
20241
20254

Applicants with the most clearances

Product code ONG
Applicants holding the most 510(k) clearances under product code ONG
ApplicantClearances
Avava, Inc.5
Solta Medical, Inc.4
Palomar Medical Products, Inc.3
Lutronic Corporation2
Palomar Medical Technologies, Inc.2
Shanghai Apolo Medical Technology Co.,Ltd.2
Tria Beauty, Inc.2
Beijing Sincoheren Science & Technology Development Co., Ltd1
Bio-Med USA, Inc.1
Eclipse Aesthetics, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order