LUNA X INC

FDA Device Registration & Listing · Sioux Falls, SD, US · Registration 3038373471

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
3038373471
FEI Number
3038373471
Entity Name
LUNA X INC
City/State/Country
Sioux Falls, SD, US
Establishment Address
4809 W 41st St Ste 202 # 171, Sioux Falls, SD 57106, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Luna X Inc (Owner Number: 10093433)
Owner / Operator Contact Address
1525 east Pama Lane, Suite 200, Las Vegas, NV 89119, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K200803
PMA Number
N/A

All Registered Proprietary Names

KIWI Derma Luna 4 Plus Peach 2 Peach 2 Pro Max Peach 2 go Peach 2 Duo FAQ 302 FAQ 101 FAQ 202 Plus FAQ 201 FAQ 202 ESPADA 2 ISSA COMPACT ISSA 2 ISSA PLAY ISSA 4 Plus ISSA baby Brush Head Pearl Pink ISSA MINI ISSA BABY ISSA 3 ISSA MIKRO ISSA BRUSH HEAD ISSA baby Brush Head Kiwi Green ISSA MINI SET ISSA MINI 2 SENSITIVE ISSA baby Brush Head Bubble Blue ISSA 2 SENSITIVE SET ISSA PRO SET ISSA 4 smile ISSA SENSITIVE ISSA 4 ISSA MINI 2 ISSA HYBRID ISSA HYBRID BRUSH HEAD ISSA ISSA Hybrid Wave Brush Head Lavender ISSA 4 baby ISSA KIDS ISSA KIDS SENSITIVE ISSA MINI HYBRID ISSA MINI 3 ISSA MINI BRUSH HEAD FAQ 103 FAQ 102 BEAR Bear 2 BEAR MINI BEAR 2 Eyes and Lips BEAR 2 go

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2025-06-02
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2025-06-02
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes Neurology Class 2 882.5890 2025-06-02
OHT Light Based Over-The-Counter Hair Removal General, Plastic Surgery Class 2 878.4810 2025-06-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-06-02
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2025-06-02
PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction General, Plastic Surgery Class 2 878.4420 2025-06-02
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2025-06-02
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2025-05-15
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2025-05-15
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2025-06-02
JEQ Toothbrush, Powered Dental Class 1 872.6865 2025-06-11
PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction General, Plastic Surgery Class 2 878.4420 2025-06-02
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2025-06-02
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes Neurology Class 2 882.5890 2025-06-02
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes Neurology Class 2 882.5890 2025-05-15

Official Correspondent

Evan Feldstein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Luna X Inc
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038373471. Last updated year: 2026. Please use registration number 3038373471 when referencing this establishment in official correspondence.
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