510(k) · Cleared
ClearedOrthoGold 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Regeneration Technologies · ISA Massager, Therapeutic, Electric
Cleared on Dec 21, 2018 as substantially equivalent to K081541 (Asclepion Laser Technologies GmbH, 2009) after an 86-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Dec 21, 2018
- Review
- 86 days
- Class
- Class I
- Product code
- ISA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081541 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK081541 Dermablate EffectAsclepion Laser Technologies GmbH · 2009
- This deviceK182682 OrthoGold 100Tissue Regeneration Technologies · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081541 | Dermablate Effect | Asclepion Laser Technologies GmbH | 2009 | — |
| 0 (this device) | K182682 | OrthoGold 100 | Tissue Regeneration Technologies | 2018 | — |
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 |
|---|---|---|---|
| * | K081541 | Dermablate EffectSummary page 4…): Manufacturer Device Name 510(k) Number Procode Class Asclepion Laser Dermablate Effect K081541 ISA I Technologies GmbH Indications for Use The OrthoGold 100™ is intended for the activation of connective… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 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 OrthoGold 100 is intended for the activation of connective tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182682: OrthoGold 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182682
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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