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FDA 510(k)

MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG

K-Number: K914677 · 1991-11-08

ApplicantSunrise Technologies, Inc.
Decision Date1991-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Technologies, Inc.. It received FDA 510(k) clearance on 1991-11-08 under 510(k) number K914677. 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 MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG?

MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG is a medical device that received FDA 510(k) clearance on 1991-11-08. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K914677.

When did MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG receive FDA 510(k) clearance?

MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG received FDA 510(k) clearance on 1991-11-08, under 510(k) number K914677.

Who is the listed applicant for MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG?

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

What is the FDA product code for MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG?

The FDA product code for MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG is GEX. This falls under the Gastroenterology category.

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Other records listing Sunrise Technologies, Inc. as applicant

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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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