510(k) · Cleared
ClearedNutritone Facial Beauty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isomers Laboratories, Inc. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Sep 4, 2008 as substantially equivalent to K040871 (Facemaster of Beverly Hills, Inc., 2005) after a 587-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Sep 4, 2008
- Review
- 587 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040871 (2005). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K102494The Buzz Facial Toning SystemDaka International, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040871 | Facemaster Facial Toning System | Facemaster of Beverly Hills, Inc. | 2005 | — |
| 0 (this device) | K070250 | Nutritone Facial Beauty System | Isomers Laboratories, Inc. | 2008 | — |
| +1 | K102494 | The Buzz Facial Toning System | Daka International, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040871 | Facemaster Facial Toning SystemSummary page 1…EDICATE DEVICE For its indication for use, the NutritoneTM Facial Beauty System is substantially equivalent to the Face Master Facial Toning System cleared by FDA under K040871. DEVICE DESCRIPTION The NutritoneTM Facial Beauty System is a battery-powered hand-held non-prescription device. Its output is… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102494 | The Buzz Facial Toning System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
The Nutritone TM Facial Beauty System is intended to stimulate the face. The device is indicated for cosmetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070250: Nutritone Facial Beauty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070250
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026