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FDA 510(k)

DERMA-LASE RUBY LASER - MODEL DLR-1

K-Number: K913256 · 1992-01-22

ApplicantDerma-Lase Co.
Decision Date1992-01-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA-LASE RUBY LASER - MODEL DLR-1 is the device name listed in this FDA 510(k) record. The listed applicant is Derma-Lase Co.. It received FDA 510(k) clearance on 1992-01-22 under 510(k) number K913256. 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 DERMA-LASE RUBY LASER - MODEL DLR-1?

DERMA-LASE RUBY LASER - MODEL DLR-1 is a medical device that received FDA 510(k) clearance on 1992-01-22. The listed applicant is Derma-Lase Co.. The 510(k) number is K913256.

When did DERMA-LASE RUBY LASER - MODEL DLR-1 receive FDA 510(k) clearance?

DERMA-LASE RUBY LASER - MODEL DLR-1 received FDA 510(k) clearance on 1992-01-22, under 510(k) number K913256.

Who is the listed applicant for DERMA-LASE RUBY LASER - MODEL DLR-1?

The FDA 510(k) record lists Derma-Lase Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMA-LASE RUBY LASER - MODEL DLR-1?

The FDA product code for DERMA-LASE RUBY LASER - MODEL DLR-1 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Derma-Lase Co. 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.

K932156MULTILINE; DLY-1K930975DERMA-LASE DLA-1 LASERK930793MULTILINE; DLY-1K924647DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST

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

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

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