OPULENT SOLUTIONS SDN.BHD.

FDA Device Registration & Listing · Bayan Lepas Pulau Pinang, MY · Registration 3013387006

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
3013387006
FEI Number
3013387006
Entity Name
OPULENT SOLUTIONS SDN.BHD.
City/State/Country
Bayan Lepas Pulau Pinang, MY
Establishment Address
Plot 111, Bayan Lepas Industrial Park, Lebuh Raya Kampung Jawa, Bayan Lepas Pulau Pinang 11900, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Opulent Solutions Sdn.Bhd. (Owner Number: 10059914)
Owner / Operator Contact Address
Plot 111, Bayan Lepas Industrial Park, Lebuh Raya Kampung Jawa, Bayan Lepas, MY-07 11900, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

REVIAN LYTE REVIAN RED GETHAIRMD HAIR GROWTH SYSTEM (10013)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2024-09-23
OAP Laser, Comb, Hair Physical Medicine Class 2 890.5500 2019-03-08

Official Correspondent

William Thoo Tze Ming

US Agent Details

Tammy Carrea Business: REVIAN, Inc Email: tcarrea@emitbio.com Phone: (919) 9315602

Related Public Records

Same Entity

Opulent Solutions Sdn.Bhd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013387006. Last updated year: 2026. Please use registration number 3013387006 when referencing this establishment in official correspondence.
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