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FDA 510(k)

SCULPTURE

K-Number: K971609 · 1997-08-14

ApplicantServizi Medico Estetici Italinai Srl.
Decision Date1997-08-14
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SCULPTURE is the device name listed in this FDA 510(k) record. The listed applicant is Servizi Medico Estetici Italinai Srl.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K971609. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCULPTURE?

SCULPTURE is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Servizi Medico Estetici Italinai Srl.. The 510(k) number is K971609.

When did SCULPTURE receive FDA 510(k) clearance?

SCULPTURE received FDA 510(k) clearance on 1997-08-14, under 510(k) number K971609.

Who is the listed applicant for SCULPTURE?

The FDA 510(k) record lists Servizi Medico Estetici Italinai Srl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCULPTURE?

The FDA product code for SCULPTURE is LFL.

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 Servizi Medico Estetici Italinai Srl. 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.

K980301IP-16

Related Devices (Code: LFL)

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.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

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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