Avava, Inc.
Waltham, MA, US
AVAVA, INC. appears in FDA device records in Waltham, MA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Avava, Inc. between 2021 and 2025. The busiest year on record is 2022, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252155 | AVAVA™ Skin Treatment System | ONG | Substantially Equivalent | |
| K250402 | AVAVA™ Skin Treatment System | ONG | Substantially Equivalent | |
| K223871 | Miria Skin Treatment System | ONG | Substantially Equivalent | |
| K221268 | SR-1 Skin Treatment System | ONG | Substantially Equivalent | |
| K213726 | PL-1 Skin Treatment System | GEX | Substantially Equivalent | |
| K202884 | SR-1 Skin Treatment System | ONG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015983416 | 3015983416 | AVAVA, INC. | 318 Bear Hill Rd, Waltham, MA 02451 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain