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FDA 510(k)

SUNETICS CLINICAL BIO-STIMULATION LASER

K-Number: K132646 · 2013-12-20

ApplicantSunetics International Marketing Group, LLC
Decision Date2013-12-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUNETICS CLINICAL BIO-STIMULATION LASER is the device name listed in this FDA 510(k) record. The listed applicant is Sunetics International Marketing Group, LLC. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132646. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNETICS CLINICAL BIO-STIMULATION LASER?

SUNETICS CLINICAL BIO-STIMULATION LASER is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Sunetics International Marketing Group, LLC. The 510(k) number is K132646.

When did SUNETICS CLINICAL BIO-STIMULATION LASER receive FDA 510(k) clearance?

SUNETICS CLINICAL BIO-STIMULATION LASER received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132646.

Who is the listed applicant for SUNETICS CLINICAL BIO-STIMULATION LASER?

The FDA 510(k) record lists Sunetics International Marketing Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNETICS CLINICAL BIO-STIMULATION LASER?

The FDA product code for SUNETICS CLINICAL BIO-STIMULATION LASER is OAP.

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 Sunetics International Marketing Group, LLC 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.

K121920LASERBRUSH

Related Devices (Code: OAP)

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

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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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