Cellfina Motor Module Device and Package
No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
6manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | 2016-09-07 |
| Record revised | 2024-05-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2016-09-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CM1 Rev G | In distribution | |
| CM1 Rev B | In distribution | |
| CM1 Rev C, D, E | In distribution | |
| CM1 Rev D | Withdrawn | |
| CM1-EU Rev A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cellfina System Disposable Tray | Ulthera Inc | 7 |
| 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 |
| Cellfina System Procedure Kit (Single Package) | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ulthera Inc | 510(k) number | 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.