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FDA 510(k)

SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM

K-Number: K952554 · 1995-08-28

ApplicantSchwartz Electro-Optics, Inc.
Decision Date1995-08-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Schwartz Electro-Optics, Inc.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K952554. 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 SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM?

SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Schwartz Electro-Optics, Inc.. The 510(k) number is K952554.

When did SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM receive FDA 510(k) clearance?

SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM received FDA 510(k) clearance on 1995-08-28, under 510(k) number K952554.

Who is the listed applicant for SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM?

The FDA 510(k) record lists Schwartz Electro-Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM?

The FDA product code for SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Schwartz Electro-Optics, 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.

K980710SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEMK980313SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASEK973867SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEMK974039SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASEK973603SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEMK971404SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER

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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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