DIGITAL SURGERY SYSTEMS, INC

FDA Device Registration & Listing · Goleta, CA, US · Registration 3015180671

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
3015180671
FEI Number
3015180671
Entity Name
DIGITAL SURGERY SYSTEMS, INC
City/State/Country
Goleta, CA, US
Establishment Address
125 Cremona Drive, Suite 110, Goleta, CA 93117, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Digital Surgery Systems (Owner Number: 10059141)
Owner / Operator Contact Address
125 Cremona Drive, Suite 110, Goleta, CA 93117, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243077
PMA Number
N/A

All Registered Proprietary Names

RE3 and accessories; Affirm 800

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSO Microscope, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4700 2021-06-25
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-06-30

Official Correspondent

Lu Ju

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Digital Surgery Systems
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 3015180671. Last updated year: 2026. Please use registration number 3015180671 when referencing this establishment in official correspondence.
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