510(k) · Cleared
ClearedInterx 1000/Derma 200 Stimulator for Cosmetic Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro Resource Group, Inc. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Apr 4, 2008 as substantially equivalent to K042912 (Neuro Resource Group, Inc., 2005) and 2 other predicates after a 437-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Apr 4, 2008
- Review
- 437 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K951951 (1996). 6 ancestors in all, the oldest K870947 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK951951 Focus Model 795 UnitEmpi · 1996
- 2 generations backK041575 Fenzian Treatment SystemEumedic Limited · 2004
- 1 generation backK042912 INTERX5000Neuro Resource Group, Inc. · 2005 · Recalled
- This deviceK070217 Interx 1000/Derma 200 Stimulator for Cosmetic UseNeuro Resource Group, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK102494 The Buzz Facial Toning SystemDaka International, Ltd. · 2011
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 |
|---|---|---|---|---|---|
| −3 | K951951 | Focus Model 795 Unit | Empi | 1996 | — |
| −2 | K041575 | Fenzian Treatment System | Eumedic Limited | 2004 | — |
| −1 | K042912 | INTERX5000 | Neuro Resource Group, Inc. | 2005 | 1 |
| 0 (this device) | K070217 | Interx 1000/Derma 200 Stimulator for Cosmetic Use | Neuro Resource Group, Inc. | 2008 | — |
| +1 | K102494 | The Buzz Facial Toning System | Daka International, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K042912 | INTERX5000Summary page 1…or Cosmetic Use Predicate Devices Device Manufacturer 510k Reference InterX 5000 Neuro Resource Group K042912 Rejuvenique Salton K011935 Facemaster Facemaster of Beverly Hills K… | 2005 |
| * | K011935 | Rejuvenique Model #RJV10Summary page 1…Manufacturer 510k Reference InterX 5000 Neuro Resource Group K042912 Rejuvenique Salton K011935 Facemaster Facemaster of Beverly Hills K040871 Product Description The InterX 1000/Derma 200 Stimulator for… | 2001 |
| * | K040871 | Facemaster Facial Toning SystemSummary page 1…Neuro Resource Group K042912 Rejuvenique Salton K011935 Facemaster Facemaster of Beverly Hills K040871 Product Description The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of… | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K102494 (Daka International, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K042912.
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?
This device is intended for cosmetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070217: Interx 1000/Derma 200 Stimulator for Cosmetic Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070217
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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