Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Gases used within eye to place pressure on detached retina

PMA Number: P900066 · 2026-04-30

ApplicantAirgas Therapeutics, LLC
Decision Date2026-04-30
PMA NumberP900066
Product CodeLPO
Device ClassClass 3
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOP

Device Summary

Gases used within eye to place pressure on detached retina is a medical device manufactured by Airgas Therapeutics, LLC. It received FDA Premarket Approval (PMA) on 2026-04-30 under PMA number P900066. The device is classified under FDA product code LPO. It was reviewed by the OP 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 O. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. 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 Gases used within eye to place pressure on detached retina?

Gases used within eye to place pressure on detached retina is a medical device that received FDA Premarket Approval (PMA) on 2026-04-30. It is manufactured by Airgas Therapeutics, LLC. The PMA number is P900066.

When did Gases used within eye to place pressure on detached retina receive FDA PMA approval?

Gases used within eye to place pressure on detached retina received FDA PMA approval on 2026-04-30, under approval number P900066.

What company makes Gases used within eye to place pressure on detached retina?

Gases used within eye to place pressure on detached retina is manufactured by Airgas Therapeutics, LLC.

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 the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Gases used within eye to place pressure on detached retina?

The FDA product code for Gases used within eye to place pressure on detached retina is LPO.

What FDA device class is Gases used within eye to place pressure on detached retina?

Gases used within eye to place pressure on detached retina is classified as Class III by the FDA.

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.

↑