TOPMD SKIN CARE, INC.

FDA Device Registration & Listing · Dallas, TX, US · Registration 3042366049

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
3042366049
FEI Number
3042366049
Entity Name
TOPMD SKIN CARE, INC.
City/State/Country
Dallas, TX, US
Establishment Address
1511 Prudential Dr, Dallas, TX 75235, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
TopMD Skin Care, Inc. (Owner Number: 10094220)
Owner / Operator Contact Address
1511 Prudential Drive, Dallas, TX 75235, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K133542
PMA Number
N/A

All Registered Proprietary Names

CLn Healing & Rescue Hypochlorous Spray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-11-19

Official Correspondent

Luis Bartolome

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TopMD Skin Care, 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
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042366049. Last updated year: 2026. Please use registration number 3042366049 when referencing this establishment in official correspondence.
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