Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015983416

FEI Number

3015983416

Entity Name

AVAVA, INC.

City/State/Country

Waltham, MA, US

Establishment Address

318 Bear Hill Rd, Ste 1, Waltham, MA 02451, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Avava, Inc. (Owner Number: 10087658)

Owner / Operator Contact Address

318 Bear Hill Rd, Ste 1, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221268

PMA Number

N/A

All Registered Proprietary Names

Avava Skin Treatment System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2023-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avava, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015983416. Last updated year: 2026. Please use registration number 3015983416 when referencing this establishment in official correspondence.