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Data / Medical devices / United States / Avava, Inc.

Avava, Inc.: FDA-registered device maker in Waltham, MA, United States, 1 510(k) clearance

Avava, Inc. is registered with the FDA (registration 3015983416) in Waltham, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015983416
Address
318 Bear Hill Rd Ste 1, Waltham, MA, United States, 02451
Owner or operator
Avava, Inc. (10087658)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
March 24, 2023
Registered through
2026
Brand names listed
Avava Skin Treatment System

Devices it lists

DeviceProduct codeClassRoleSource
Powered Laser Surgical Instrument With MicrobeamFractional OutputONG2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 21, 2022K221268SR-1 Skin Treatment SystemONGSubstantially EquivalentAVAVA, Inc.accessdata.fda.gov

Compare with other makers

Updated November 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.