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.

Renuva 1550 · Powered Laser Surgical Instrument with MicrobeamFractional Output → General & Plastic Surgery

Name: Renuva 1550
Brand: Renuva 1550

12manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

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 Renuva 1550
Listed by	Wingderm Electro-Optics Ltd., China
FDA product code	ONG
Device type	Powered Laser Surgical Instrument With MicrobeamFractional Output
Device class	Class 2
Regulation	21 CFR 878.4810
Establishment	Manufacturer, Exporter
510(k)	K192350
Record published	2020-11-16

Specifications

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

Catalogue Numbers

Catalogue numbers for Renuva 1550
Catalogue number	Size	Status
WFB-01		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	Solta Medical, Inc.	8
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

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
K192350	2020-04-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Renuva 1550
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason
Wingderm Electro-Optics Ltd.	510(k) number	2024-08-23	Class II	Radiation Control for Health and Safety Act	Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)

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.

Renuva 1550