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FDA PMA

System, laser, fiber optic, photodynamic therapy

PMA Number: P940010 · 2021-02-24

ApplicantPinnacle Biologics, Inc.
Decision Date2021-02-24
PMA NumberP940010
Product CodeMVG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeSU

Device Summary

System, laser, fiber optic, photodynamic therapy is the device name listed in this FDA PMA record. The listed applicant is Pinnacle Biologics, Inc.. It received FDA Premarket Approval (PMA) on 2021-02-24 under PMA number P940010. The device is classified under FDA product code MVG. It was reviewed by the SU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is System, laser, fiber optic, photodynamic therapy?

System, laser, fiber optic, photodynamic therapy is a medical device that received FDA Premarket Approval (PMA) on 2021-02-24. The listed applicant is Pinnacle Biologics, Inc.. The PMA number is P940010.

When did System, laser, fiber optic, photodynamic therapy receive FDA PMA approval?

System, laser, fiber optic, photodynamic therapy received FDA PMA approval on 2021-02-24, under PMA number P940010.

Who is the listed applicant for System, laser, fiber optic, photodynamic therapy?

The FDA PMA record lists Pinnacle Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for System, laser, fiber optic, photodynamic therapy?

The FDA product code for System, laser, fiber optic, photodynamic therapy is MVG.

What FDA device class is System, laser, fiber optic, photodynamic therapy?

System, laser, fiber optic, photodynamic therapy is classified as Class III by the FDA.

Other records listing Pinnacle Biologics, 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.

PMA P990021System, laser, photodynamic therapy

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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