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Optical Biopsy System

by Spectra Science

PMA P990050

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P990050↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP990050 Date14 Nov 2000ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Wavstat (Tm) Optical Biopsy System
Trade Name
Optical Biopsy(Tm) System
Generic Name
ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
PMA Number
FDA Product Code
MOA
Device Class
Class III
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Optical Biopsy System is a fiber optic diagnostic analyzer designed for use in lower gastrointestinal endoscopy. Classified as a Class III device, it provides optical evaluation of polyps less than 1 cm in diameter to assist in determining whether they should be removed for histological examination.

This device is intended for use as an adjunct during lower GI endoscopy and is supplied as a reusable medical instrument. Authorized under FDA PMA (P990050), it is regulated under the Gastroenterology and Urology advisory committees. No specific sterility or MRI safety information is provided in the data.

Other devices from Spectra Science

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What specific clinical scenario is the WAVSTAT Optical Biopsy System designed to assist with during a lower GI endoscopy?

    The WAVSTAT Optical Biopsy System is intended to help evaluate polyps less than 1 cm in diameter during lower gastrointestinal endoscopy. It assists physicians in determining whether these polyps should be removed for further histological examination, particularly when the clinician has not already decided to remove them.

  • Is the WAVSTAT Optical Biopsy System a single-use or reusable device, and what does this mean for its maintenance?

    The WAVSTAT Optical Biopsy System is supplied as a reusable medical instrument. This means it is designed to be cleaned, disinfected, and sterilized between uses, following proper reprocessing protocols to maintain its performance and safety for subsequent procedures.

  • How was the regulatory approval for this device obtained, and which committees were involved in its review?

    The WAVSTAT Optical Biopsy System received FDA approval through a Premarket Approval (PMA) application (PMA #P990050). The device was reviewed under the jurisdiction of the Gastroenterology and Urology advisory committees, specifically the Gastroenterology and Urology (GU) panel, as indicated by its product code (MOA).

  • What are the key limitations or considerations when using the WAVSTAT Optical Biopsy System in clinical practice?

    The system is only intended for use in deciding whether polyps less than 1 cm in diameter *should be removed*—it does not replace histological examination or final diagnostic decisions. It is not meant for polyps already selected for removal, nor does it provide definitive diagnosis on its own. Additionally, since it is reusable, proper reprocessing is critical to ensure accuracy and safety between uses.