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FDA 510(k)

LASETTE LASER SKIN PERFORATOR

K-Number: K981149 · 1998-06-29

ApplicantCell Robotics, Inc.
Decision Date1998-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASETTE LASER SKIN PERFORATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cell Robotics, Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981149. 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 LASETTE LASER SKIN PERFORATOR?

LASETTE LASER SKIN PERFORATOR is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Cell Robotics, Inc.. The 510(k) number is K981149.

When did LASETTE LASER SKIN PERFORATOR receive FDA 510(k) clearance?

LASETTE LASER SKIN PERFORATOR received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981149.

Who is the listed applicant for LASETTE LASER SKIN PERFORATOR?

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

What is the FDA product code for LASETTE LASER SKIN PERFORATOR?

The FDA product code for LASETTE LASER SKIN PERFORATOR is GEX. This falls under the Gastroenterology category.

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Other records listing Cell Robotics, 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.

K033799CLINICAL LASETTE P-200K021946CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEMK983673LASETTEK981746CELL ROBOTICS' LASETTEK982230LASETTE LASER SKIN PERFORATORK973431LASETTE

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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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