Cellfina System Procedure Kit (Single Package)
Catalogue number CK1-1 Rev. A, listed by Ulthera 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
4510(k) clearances naming this product code
1recall
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 | Ulthera 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 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K153677 |
| Record published | 2016-12-12 |
| Record revised | 2024-05-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2016-12-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CK1-1 Rev. A | 5 | Withdrawn |
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 |
| Aveli | Revelle Aesthetics, Inc. | 1 |
| Cellfina System Disposable Procedure Kit | Ulthera Inc | 1 |
| Cellfina Prep Pack for EU | Ulthera Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192185 | 2019-10-09 |
| K161885 | 2016-10-05 |
| K153677 | 2016-02-25 |
| K150505 | 2015-07-29 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-11-14 | Class II | Other | It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. | 6562 units | 2017-09-13 |
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.