Aveli
Catalogue number AVE002, listed by Revelle Aesthetics, Inc., United States, under Powered Surgical Instrument For Improvement In The Appearance Of Cellulite. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (4), Hebei (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
Record
| Listed by | Revelle Aesthetics, Inc., United States |
|---|---|
| FDA product code | OUP |
| Device type | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4790 |
| 510(k) | K212399 |
| Record published | 2024-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 15 to 90 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AVE002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cellfina System Disposable Tray | Ulthera Inc | 7 |
| Cellfina Motor Module Device and Package | Ulthera Inc | 5 |
| Cellfina Prep Pack | Ulthera Inc | 3 |
| Cellfina System Cart | Ulthera Inc | 1 |
| Cellfina | Ulthera Inc | 1 |
| Cellfina System Disposable Procedure Kit | Ulthera Inc | 1 |
| Cellfina Prep Pack for EU | Ulthera Inc | 1 |
| Cellfina System Procedure Kit (Single Package) | Ulthera Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232153 | 2023-08-18 |
| K221336 | 2022-08-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.