AVAVA, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “AVAVA, Inc.” (first 2021, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 189 days. Since 2017 the median was 189 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 197 |
| 2022 | 2 | 208 |
| 2023 | 1 | 181 |
| 2024 | 0 | — |
| 2025 | 2 | 82 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name AVAVA, Inc. took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 5 | 5 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent AVAVA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252155 | AVAVA Skin Treatment System | ONG | 2025-10-20 | 103 |
| K250402 | AVAVA Skin Treatment System | ONG | 2025-04-14 | 61 |
| K223871 | Miria Skin Treatment System | ONG | 2023-06-22 | 181 |
| K221268 | SR-1 Skin Treatment System | ONG | 2022-11-21 | 203 |
| K213726 | PL-1 Skin Treatment System | GEX | 2022-06-28 | 214 |
| K202884 | SR-1 Skin Treatment System | ONG | 2021-04-13 | 197 |
Recalls
openFDA lists no recalls under a recalling firm named AVAVA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named AVAVA, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06868615: AVAVA MIRIA General Use (Recruiting, started 2024-09-11)
- NCT06557434: AV-23-001 AVAVA MIRIA Pilot Study (Active not recruiting, started 2023-11-06)
- NCT05597267: The MIRIA Acne Scar Study (Active not recruiting, started 2022-11-04)
- NCT04925921: AVAVA SR-1 Wrinkles and BPL Study (Completed, started 2021-05-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under AVAVA, Inc.?
FDA lists 6 510(k) clearances under the applicant name “AVAVA, Inc.” (first 2021, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by AVAVA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name AVAVA, Inc. is 189 days. Since 2017: 189 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under AVAVA, Inc.?
The most frequent FDA product codes under this applicant name are ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 5); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 6 AVAVA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ONG, AVAVA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.