510(k) · Cleared
ClearedCynosure Triactive Therapeutic Massage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · ISA Massager, Therapeutic, Electric
Cleared on Jan 22, 2004 after a 308-day review. The FDA summary names its predicate without a number. 133 later devices descend from it.
- Decided
- Jan 22, 2004
- Review
- 308 days
- Class
- Class I
- Product code
- ISA
- Recalls
- None
- Predicates
- 0
133 later devices descend from it, 5 citing it directly.
- This deviceK030876 Cynosure Triactive Therapeutic Massage SystemCynosure, Inc. · 2004
- Descendant · cites it directly · 101 of its ownK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- Descendant · 2 generations on · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · 2 generations on · 45 of its ownK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- Descendant · cites it directly · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · cites it directly · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008 · cites it directly101descendants
- K090221Reaction SystemViora, Ltd. · 2009 · 2 generations on54descendants
- K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009 · 2 generations on45descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · cites it directly35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · cites it directly34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030876 | Cynosure Triactive Therapeutic Massage System | Cynosure, Inc. | 2004 | — |
| +1 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| +2 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +2 | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| +1 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +1 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 13 | 0 |
| 2017 | 11 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 11 | 0 |
| 2023 | 10 | 0 |
| 2024 | 12 | 0 |
| 2025 | 15 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | — | LPG Therapeutic Massager and Vibrator Named without a submission number |
What descends from it? (133)
See all 1335 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?
- Of its descendants, K080300 (Cutera, Inc., 2008) has gone furthest, with 101 descendants of its own.
How does its category compare?
All ISA devicesISA Massager, Therapeutic, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Relieves minor muscle aches and pains
Relieve muscle spasm
Temporary Improvement in local circulation -
Temporarily reduces the appearance of cellulite
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030876: Cynosure Triactive Therapeutic Massage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030876
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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