510(k) · Cleared
ClearedD-Actor 200 Vibration Massage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Medical AG · ISA Massager, Therapeutic, Electric
Cleared on Apr 13, 2018 as substantially equivalent to K081541 (Asclepion Laser Technologies GmbH, 2009) and 1 other predicate after a 133-day review. Its family tree reaches back 14 generations to 1995. 6 later devices descend from it.
- Decided
- Apr 13, 2018
- Review
- 133 days
- Class
- Class I
- Product code
- ISA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 191 ancestors in all, the oldest K800617 (1980). 6 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- This deviceK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
- Descendant · cites it directly · 2 of its ownK210451 OrthoGold 100Tissue Regeneration Technologies, LLC · 2021
- Descendant · cites it directly · 1 of its ownK220538 DolorClast RadialE.M.S Electro Medical Systems S.A · 2022
- Descendant · cites it directly · 0 of its ownK243488 Vmat ProTermosalud · 2025
- Descendant · cites it directly · 0 of its ownK221865 BTL-094BTL Industries, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK210166 Omnispec ED1000Medispec, Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK112669 Tattoostar Effect YAsclepion Laser Technologies GmbH · 2012
- This deviceK173692 D-Actor 200 Vibration Massage SystemStorz Medical AG · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210451OrthoGold 100Tissue Regeneration Technologies, LLC · 2021 · cites it directly2descendants
- K220538DolorClast RadialE.M.S Electro Medical Systems S.A · 2022 · cites it directly1descendant
- K243488Vmat ProTermosalud · 2025 · cites it directly0descendants
- K221865BTL-094BTL Industries, Inc. · 2023 · cites it directly0descendants
- K210166Omnispec ED1000Medispec, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −1 | K112669 | Tattoostar Effect Y | Asclepion Laser Technologies GmbH | 2012 | — |
| 0 (this device) | K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018 | — |
| +1 | K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021 | — |
| +1 | K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022 | — |
| +1 | K243488 | Vmat Pro | Termosalud | 2025 | — |
| +1 | K221865 | BTL-094 | BTL Industries, Inc. | 2023 | — |
| +1 | K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 16 | 0 |
| 1997 | 18 | 0 |
| 1998 | 11 | 0 |
| 1999 | 7 | 0 |
| 2000 | 18 | 0 |
| 2001 | 14 | 0 |
| 2002 | 22 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 ISA? 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 ISA device
- #1 K243488 Vmat Proscore 13.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K081541 | Dermablate EffectSummary page 4…quivalence claimed to the Acoustic Wave (AW) module component (i.e., D-Actor Vibration Massage System provided OEM) of the Dermablate Effect, submission number K081541 and the TattooStar Effect Y, submission number K112669. AW Module (D-Actor provided OEM): Classification Name: M… | 2009 |
| * | K112669 | Tattoostar Effect YSummary page 4…ponent (i.e., D-Actor Vibration Massage System provided OEM) of the Dermablate Effect, submission number K081541 and the TattooStar Effect Y, submission number K112669. AW Module (D-Actor provided OEM): Classification Name: Massager, Therapeutic, Electric Product Code:… | 2012 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 8 of the 191 ancestors have a recall of any class.
- Of its descendants, K210451 (Tissue Regeneration Technologies, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K081541.
How does its category compare?
All ISA devicesISA Massager, Therapeutic, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · ISA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ISA
Too few ISA 510(k)s in any year since 2007 to give a median.
Recalls per year · ISA
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISA
16in 2025
MAUDE reports naming product code ISA, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 2 | 16 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The D-ACTOR® 200 Vibration Massage System is intended for:
• Relief of minor muscle aches and pains
• Temporary increase in local blood circulation
• Activation of connective tissue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173692: D-Actor 200 Vibration Massage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173692
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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