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FDA 510(k)

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER

K-Number: K971404 · 1997-07-09

ApplicantSchwartz Electro-Optics, Inc.
Decision Date1997-07-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER 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 1997-07-09 under 510(k) number K971404. 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. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER?

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Schwartz Electro-Optics, Inc.. The 510(k) number is K971404.

When did SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER receive FDA 510(k) clearance?

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971404.

Who is the listed applicant for SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER?

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. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER?

The FDA product code for SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER 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 SYSTEMK953585SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER

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Related Devices (Code: GEX)

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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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