PMA

P220007: Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

FDA PMA · Lenses, soft contact, extended wear · Alcon Laboratories, Inc.

Key facts

PMA number P220007
Trade name Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta
Generic name Lenses, soft contact, extended wear
Applicant Alcon Laboratories, Inc.
Owner/operator Alcon Laboratories, Inc.
Product code LPM
Approval date Apr 25, 2023
Docket number 23M-1659
Establishment registration 1610287
FEI number 1610287

At a glance

  • 1–9 Supplements
  • Mar 11, 2026 Latest supplement decision
  • No Withdrawn
  • Yes Summary of safety and effectiveness on file
  • None UDI device identifiers (GUDID)
  • None MAUDE adverse event reports
  • None Recall events

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA approvals

Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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