PLANDOCS USA, INC.

FDA Device Registration & Listing · Orange, CA, US · Registration 3030446758

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
3030446758
FEI Number
3030446758
Entity Name
PLANDOCS USA, INC.
City/State/Country
Orange, CA, US
Establishment Address
500 N State College Blvd Ste 1100, Orange, CA 92868, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Plandocs USA, Inc. (Owner Number: 10091336)
Owner / Operator Contact Address
500 N. State College Blvd,, Suite 1100, Orange, CA 92868, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K230420
PMA Number
N/A

All Registered Proprietary Names

PD NANO CANNULA DermiSync™ Lumeon_Pro Dr.pen A20

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-04-24
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-02-13
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2025-03-25

Official Correspondent

Jamie Park

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Plandocs USA, 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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030446758. Last updated year: 2026. Please use registration number 3030446758 when referencing this establishment in official correspondence.
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