SPECTRUM ASSEMBLY INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3002672225

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
3002672225
FEI Number
3002672225
Entity Name
SPECTRUM ASSEMBLY INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
6300 Yarrow Dr, SUITE 100, Carlsbad, CA 92011, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SPECTRUM ASSEMBLY INC. (Owner Number: 9103619)
Owner / Operator Contact Address
6300 Yarrow Dr, Suite 100, Carlsbad, CA 92011, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Skylit Phototherapy System TrueRelief

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2017-10-11
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2021-09-17

Official Correspondent

MICHAEL BALDWIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPECTRUM ASSEMBLY 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
K800950 Tanit, Inc. TANIT HOME SUNTANNING UNIT 1980-06-04
K230382 Daavlin Distributing Co. 3 Series NeoLux 2023-03-24
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002672225. Last updated year: 2026. Please use registration number 3002672225 when referencing this establishment in official correspondence.
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