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FDA 510(k)

TRU-PULSE LASER (MODIFIED)

K-Number: K963683 · 1997-02-12

ApplicantTissue Technologies, Inc.
Decision Date1997-02-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRU-PULSE LASER (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Technologies, Inc.. It received FDA 510(k) clearance on 1997-02-12 under 510(k) number K963683. 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 TRU-PULSE LASER (MODIFIED)?

TRU-PULSE LASER (MODIFIED) is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Tissue Technologies, Inc.. The 510(k) number is K963683.

When did TRU-PULSE LASER (MODIFIED) receive FDA 510(k) clearance?

TRU-PULSE LASER (MODIFIED) received FDA 510(k) clearance on 1997-02-12, under 510(k) number K963683.

Who is the listed applicant for TRU-PULSE LASER (MODIFIED)?

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

What is the FDA product code for TRU-PULSE LASER (MODIFIED)?

The FDA product code for TRU-PULSE LASER (MODIFIED) is GEX. This falls under the Gastroenterology category.

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Other records listing Tissue Technologies, 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.

K002071SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLESK000849SOFTFORM FACIAL IMPLANTK982475SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOLK973462SOFTFORM FACIAL IMPLANTK970804TRU-PULSE CO2 SURGICAL LASERK962496SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)

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Related Devices (Code: GEX)

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.

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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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