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FDA 510(k)

MED SCULPT

K-Number: K053041 · 2006-08-02

ApplicantGeneral Project S.R.L.
Decision Date2006-08-02
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MED SCULPT is the device name listed in this FDA 510(k) record. The listed applicant is General Project S.R.L.. It received FDA 510(k) clearance on 2006-08-02 under 510(k) number K053041. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MED SCULPT?

MED SCULPT is a medical device that received FDA 510(k) clearance on 2006-08-02. The listed applicant is General Project S.R.L.. The 510(k) number is K053041.

When did MED SCULPT receive FDA 510(k) clearance?

MED SCULPT received FDA 510(k) clearance on 2006-08-02, under 510(k) number K053041.

Who is the listed applicant for MED SCULPT?

The FDA 510(k) record lists General Project S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED SCULPT?

The FDA product code for MED SCULPT is IMI.

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Other records listing General Project S.R.L. 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.

K161502MC1 PlusK091615MED CONTOURK062312AXIOM PULSED LIGHT SYSTEMK051508MED FLASH II INTENSE PULSED LIGHT SYSTEM.

Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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