Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011170521

FEI Number

3011170521

Entity Name

Shenzhen Fortunecome Technology Co.,Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

NO.57,SHANGXIA ROAD,BAOAN COMMUNITY,YUANSHAN STREET,LONGGANG DISTRICT, Shenzhen Guangdong 518115, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Shenzhen Fortunecome Technology Co.,Ltd. (Owner Number: 10047995)

Owner / Operator Contact Address

NO.57,SHANGXIA ROAD,BAOAN COMMUNITY,YUANSHAN STREET,LONGGANG DISTRICT, Shenzhen, CN-GD 518115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FL-V36; FL-V41; FL-V42; FL-V43; FL-V5; FL-V5-X1; FL-V6; FL-V8; FL-V8-X1; FL-V8L; FL-V9; FL-V16; FL-V17; FL-V18; FL-V19; FL-V20; FL-V22; FL-V23; FL-V24; FL-V26; FL-V27; Unit, Oral Irrigation - D008; N008; ORAL IRRIGATOR; V18plus; V8plus; WF-03; X01; X02; X03; JYQ831; JYQ832; JYQ833; JYQ834; JYQ835; JYQ836; JYQ837; JYQ838; JYQ839; JYQ840; JYQ841; JYQ842; JYQ843; JYQ844; JYQ845 HL-B1; IP-1501; M008; Model No.: FL-V2012; Model No.: FL-V2101, FL-V2102, FL-V2103, FL-V2104, FL-V2105, FL-V2106, FL-V2107, FL-V2108, FL-V2109, FL-V2110, FL-V2111; Oral Plaque & Tartar Remover Kit: FL-V34; FL-V38; FL-V39; FL-V40; C11; C22; C33; C44; C66; C77; C88; C99 FL-V28; FL-V29; FL-V30; FL-V31; FL-V32; FL-V33; FL-V35; YASI 911; YASI 912; YASI 913; YASI 915; YASI 916; YASI 917; Model No.:FL-V21-X1, FL-V22-X1, FL-V23-X1, FL-V25-X1, FL-V26-X1, FL-V28-X1, FL-V29-X1, FL-V30-X1, FL-V31-X1 Model No.: FL-V32-X1, FL-V33-X1, FL-V35-X1, FL-V36-X1 Model No.: YY-C02, YY-C03, YY-C04, YY-C05, YY-C06, FL-V5-X1, FL-V8-X1, FL-V8L-X1, FL-V17-X1, FLV-18-X1, FL-V19-X1, FL-V20-X1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2014-11-23
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2021-01-25
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2015-01-28
MCF	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile	Dental	Class 1	872.6855	2015-01-28
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2015-01-28

Official Correspondent

Annie Ye

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Shenzhen Fortunecome Technology Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011170521. Last updated year: 2026. Please use registration number 3011170521 when referencing this establishment in official correspondence.