Data / Medical devices / United States / Face Online Store LLC
Face Online Store LLC: FDA-registered device maker in New York, NY, United States, 8 510(k) clearances
Face Online Store LLC is registered with the FDA (registration 3016661372) in New York, NY, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 28, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016661372
- Address
- 1485 5th Ave Apt 24 A, New York, NY, United States, 10035
- Owner or operator
- Face Online Store LLC (10075687)
- Roles
- Repackager or relabeler
- First device listed
- September 6, 2020
- Registered through
- 2026
- Brand names listed
- FOS Butterfly needle, Lambda Fx CO2 Laser, Lambda Fx Erbium, Lambda Fx IPL, Lambda Fx Jet Peel, Lambda Fx Laser Hair Platform, Lambda Fx PDT, Lambda Fx Pro Hair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2020 | K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) | FPA | Substantially Equivalent | Jiangsu Kangbao Medical Equipment Co., Ltd. | accessdata.fda.gov |
| May 21, 2020 | K200751 | Photodynamic Therapy (PDT) Equipment | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| April 30, 2020 | K192350 | Medical Non-Ablative Fractional Laser Systems | ONG | Substantially Equivalent | Wingderm Electro-Optics , Ltd. | accessdata.fda.gov |
| December 6, 2019 | K192521 | Intense Pulsed Light Treatment System | ONF | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| April 15, 2019 | K182924 | Diode Laser Treatment System | GEX | Substantially Equivalent | Weifang KM Electronics Co., Ltd. | accessdata.fda.gov |
| April 17, 2018 | K180353 | Diode laser hair removal device | GEX | Substantially Equivalent | Zhengzhou PZ Laser Slim Technology Co., Ltd. | accessdata.fda.gov |
| July 6, 2017 | K162398 | CO2 Laser Therapy Systems | ONG | Substantially Equivalent | Beijing Sincoheren Science and Technology Development Co. | accessdata.fda.gov |
| November 18, 2016 | K162994 | Capillus302, Capillus312, Capillus352 | OAP | Substantially Equivalent | Capillus, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Powered Laser Surgical Instrument
- All makers of Laser, Comb, Hair
- All makers of Cannula, Surgical, General & Plastic Surgery
Updated July 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.