What is FDA product code ONG?

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.

Clear & Brilliant · Powered Laser Surgical Instrument with MicrobeamFractional Output → General & Plastic Surgery

Name: Clear & Brilliant
Brand: Clear & Brilliant

12manufacturers in China registered for this device type

8catalogue numbers in this listing

3510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Beijing (7), Jiangsu (2), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ONG
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Beijing Beautemax Technology Limited	Beijing	Beijing	Contract manufacturer	13
Beijing Spiritlaser Science & Technology Co., Ltd.	Beijing	Beijing	Contract manufacturer	21
Beijing Winkonlaser Technology Limited	Beijing	Beijing	Contract manufacturer	14
Beijing Perfectlaser Technology Co., Ltd.	Beijing	Beijing	Manufacturer	12
Sanhe Jumei Technology Co., Ltd.	Sanhe	Hebei	Manufacturer	12
Beijing SEA Heart International Science AND Technology Co., Ltd.	Beijing	Beijing	Exporter	7
Shanghai Apolo Medical Technology Co., Ltd.	Shanghai	Shanghai	Manufacturer	5
Beijing Sincoheren Science & Technology Development Co., Ltd.	Bejing	Beijing	Repacker / relabeller	5
Weifang Mingliang Electronics Co., Ltd.	Weifang	Shandong	Manufacturer	2
Wingderm Electro-Optics Ltd.	Beijing	Beijing	Manufacturer	2
Olemy Laser Technology Ltd	Wuxi	Jiangsu	Manufacturer	1

Record

Regulatory record for Clear & Brilliant
Listed by	Solta Medical, Inc., United States
FDA product code	ONG
Device type	Powered Laser Surgical Instrument With MicrobeamFractional Output
Device class	Class 2
Regulation	21 CFR 878.4810
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2016-09-23
Record revised	2021-05-24 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Clear & Brilliant
Catalogue number	Size	Status
CB-HP-1927-R		In distribution
CB-HP-1440-R		In distribution
CB-HP-1927		In distribution
CB-HP-1440		In distribution
CB-CONSOLE-R		In distribution
CB-CONSOLE		In distribution
CB-TIP-SCP		In distribution
CB-TIP-SC		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
eCO2 3D	Cynosure Lutronic Technology Corporation	18
Clear+brilliant Touch	Solta Medical, Inc.	7
Edge Guide Tip	Jeisys Medical Inc.	5
Edge Handpiece	Jeisys Medical Inc.	3
Apolomed	Shanghai Apolo Medical Technology Co., Ltd.	3
Emerge	Cynosure, LLC	2
Miria	Avava, Inc.	2
Max R Handpiece	Cynosure, LLC	2
Smooth Beauty Laser	Tria Laser Inc	2
1064+ Handpiece	Cynosure, LLC	2
Stellar™ M22	Lumenis, Ltd.	2
Emerge Handpiece	Cynosure, LLC	2

Showing 12 of 59. All products under Powered Laser Surgical Instrument With MicrobeamFractional Output

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K120433	2012-04-02
K110349	2011-05-03
K091420	2009-10-14

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-03-20	Class II	Labeling Change Control	Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.	1077 units	2015-04-27
2010-12-15	Not classified	Software design	The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.	352 units	2011-11-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Clear & Brilliant