REJUVA FRESH LLC

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3033844600

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033844600
FEI Number
3033844600
Entity Name
REJUVA FRESH LLC
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
Room 506, Block B, Shenzhen Duocai Huiwei Cultural and Creative Expo City, No. 5010 Bao'an Avenue, Caowei Community, Hangcheng Street, Bao'an District, Shenzhen Guangdong 518101, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Rejuva Fresh LLC (Owner Number: 10091638)
Owner / Operator Contact Address
Room 506, Block B, Shenzhen Duocai Huiwei Cultural and Creative Expo City, No. 5010 Bao'an Avenue, Caowei Community, Hangcheng Street, Bao'an District, Shenzhen, CN-GD 518101, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212611
PMA Number
N/A

All Registered Proprietary Names

Rejuva Fresh Reveal PRO - SuperPulse CO2 Laser Rejuva Fresh Dynamic 4 Wave Nano-Erase - ND YAG Laser System Rejuva Fresh Luna Ink Pro - ND YAG Laser System Rejuva Fresh Spot Flex Vertical - Diode Laser with Multiple Spot Sizes Rejuva Fresh DermaLaze Delicate Spectrum - ELight Intense Pulsed Light System DermaLaze Rejuva Fresh DermaLaze Delicate Portable - ELight Intense Pulsed Light System DermaLaze Rejuva Fresh DermaLaze Delicate Pro 3 in 1 - ELight Intense Pulsed Light System DermaLaze Rejuva Fresh DuoSmooth - Diode Hair Removal Laser and IPL System Rejuva Fresh SMAS Prime Focus Rejuva Fresh 7 in 1 Hydro Dermabrasion Rejuva Fresh Perfect Face Neo 6D Rejuva Fresh LuminaTight 10D Rejuva Fresh Oxi-Infuse Rejuva Fresh 360 Ultraformation HIFU Rejuva Fresh Pro Secret Icy Gold Rejuva Fresh Rejuva 9D Rejuva 7D HIFU Rejuva Fresh 18 in 1 Hydra Spa Infusion Ultra Glow Rejuva Fresh Proteus-V Rejuva Fresh Eos Restore Double Rejuva Fresh FroLift Rejuva Fresh Beauty Disruptor Rejuva Fresh DermaLuxx PRO Aqua Platinum Lift Rejuva Fresh Metamorph8.5 Rejuva Fresh HYDRA Perfection MD Rejuva Fresh LUCIDITY II Dual-Wavelength Laser Rejuva Fresh 15 in 1 Hydra Beauty Rejuva Fresh Illustria Rejuva Fresh Diamond Ice Rejuva Fresh FlowWave FOCUS PlasmaMax Pro 8D Multi-Functional Cold & Hot, Light Goddess PRO Therapeutic Skin Revitalizer Rejuva Fresh Hera Multi-Wave Rejuva Fresh Green Sapphire + EMShape Neo COMBO Rejuva Fresh Diamond Ice 360 Degrees Cryo Rejuva Fresh SlimSphere Rejuva Fresh CelluSpice Rejuva Fresh U-Shape 2 Rejuva Fresh Green Sapphire 10D Rejuva Fresh Minervix Rejuva Fresh CoolRestore Elegance Rejuva Fresh MultiNexis Rejuva Fresh Professional 3rd Gen Shockwave Therapy T8+ Rejuva Fresh CaviTONE LEGACY Complete Rejuva Fresh Roller-Wave Slimming Machine Rejuva Fresh Eris Lipo Cavitation 9 on 1 Rejuva Fresh Eris Lipo Cavitation 6 on 1 Rejuva Fresh Adonis Rejuva Fresh Proteus-V - RF Microneedling Machine Rejuva Fresh Gold Beauty - RF Microneedling Machine Rejuva Fresh Beauty Disruptor - RF Microneedling Machine Rejuva Fresh Metamorph8.5 - RF Microneedling Machine Rejuva Fresh Pro Secret Icy Gold - RF Microneedling Machine Rejuva Fresh Cool PARE Expert - Fractional CO2 Laser Rejuva Fresh CaviTONE LEGACY- Multi-application Aesthetic Platform Rejuva Fresh Custom CORE 8D - Multi-application Aesthetic Platform Rejuva Fresh Rejuva Shape - Multi-application Aesthetic Platform Rejuva Fresh U-Shape 2 - Multi-application Aesthetic Platform Rejuva Fresh Myriad - Multi-application Aesthetic Platform Rejuva Fresh REVIVO Dual Summit, Rejuva Fresh REVIVO Dual - Multi-application Aesthetic Platform Rejuva Fresh PERFECT FACE NEO Skin Ultra 7D - EMS Stimulator Device Rejuva Fresh PERFECT FACE NEO 6D - EMS Stimulator Device Rejuva Fresh True-Flex - EMS Stimulator Device Rejuva Fresh NowFlex PRO - EMS Stimulator Device Rejuva Fresh Multifunction Laser System Myriad 4 in 1 Rejuva Fresh PicoPretty 4D Complete - PicoPretty Picosecond Laser Rejuva Fresh PicoPretty Transform 3D - PicoPretty Picosecond Laser Rejuva Fresh PicoPretty 750 - PicoPretty Picosecond Laser Rejuva Fresh PicoPretty Ultralight 450 - PicoPretty Picosecond Laser Rejuva Fresh PicoPretty Ultralight 300 - PicoPretty Picosecond Laser Rejuva Fresh Rejuva Ice Aesthetic Laser Skin Cooling Machine Rejuva Fresh ReDerma ER:YAG - Aesthetic Fractional Laser System Rejuva Fresh ReDerma CO2 - Aesthetic Fractional Laser System Rejuva Fresh CO2 Laser System Smart Pulse COOL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-03-12
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-02-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-02-20
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2025-02-20
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2024-10-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-04-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-03-12
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-08-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-18
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-04-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-02-20

Official Correspondent

Huapei Cai

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Rejuva Fresh LLC
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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033844600. Last updated year: 2026. Please use registration number 3033844600 when referencing this establishment in official correspondence.
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