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FDA 510(k)

F1 DIODE LASER SYSTEM

K-Number: K030235 · 2003-04-23

ApplicantOpus Medical, Inc.
Decision Date2003-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

F1 DIODE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Opus Medical, Inc.. It received FDA 510(k) clearance on 2003-04-23 under 510(k) number K030235. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F1 DIODE LASER SYSTEM?

F1 DIODE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-23. The listed applicant is Opus Medical, Inc.. The 510(k) number is K030235.

When did F1 DIODE LASER SYSTEM receive FDA 510(k) clearance?

F1 DIODE LASER SYSTEM received FDA 510(k) clearance on 2003-04-23, under 510(k) number K030235.

Who is the listed applicant for F1 DIODE LASER SYSTEM?

The FDA 510(k) record lists Opus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F1 DIODE LASER SYSTEM?

The FDA product code for F1 DIODE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Opus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042584OPUS MINIMAGNUM ANCHOR WITH INSERTERK042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEK042031OPUS SPEEDSTITCH SUTURE DEVICEK041440OPUS MAGNUM ANCHOR WITH INSERTERK033317SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070K030170REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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