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FDA 510(k)

SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS

K-Number: K883563 · 1988-09-27

ApplicantSharplan Lasers, Inc.
Decision Date1988-09-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1988-09-27 under 510(k) number K883563. 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 SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS?

SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS is a medical device that received FDA 510(k) clearance on 1988-09-27. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K883563.

When did SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS receive FDA 510(k) clearance?

SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS received FDA 510(k) clearance on 1988-09-27, under 510(k) number K883563.

Who is the listed applicant for SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS?

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

What is the FDA product code for SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS?

The FDA product code for SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan Lasers, Inc. as applicant

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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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