510(k) · Cleared
ClearedAcculaser Pro Low Level Laser Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acculaser, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Jul 29, 2002 as substantially equivalent to K010175 (Microlight Corporation of America, 2002) after a 151-day review. Its family tree reaches back 1 generation to 2002. 19 later devices descend from it.
- Decided
- Jul 29, 2002
- Review
- 151 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010175 (2002). 19 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
- This deviceK020657 Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · cites it directly · 6 of its ownK030226 Thor Ddii 830CL3 Laser SystemThor Intl. · 2003
- Descendant · 3 generations on · 2 of its ownK083202 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · cites it directly · 2 of its ownK023060 Acculaser PRO4Acculaser, Inc. · 2004
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K050668GRT Lite, Model 8-aGrt Solutions, Inc. · 2006 · cites it directly9descendants
- K081141Combocare 2000Xanacare Technologies, LLC · 2008 · 2 generations on6descendants
- K030226Thor Ddii 830CL3 Laser SystemThor Intl. · 2003 · cites it directly6descendants
- K083202Combocare 2000Xanacare Technologies, LLC · 2008 · 3 generations on2descendants
- K023060Acculaser PRO4Acculaser, Inc. · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| 0 (this device) | K020657 | Acculaser Pro Low Level Laser Therapy Device | Acculaser, Inc. | 2002 | — |
| +1 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| +2 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +1 | K030226 | Thor Ddii 830CL3 Laser System | Thor Intl. | 2003 | — |
| +3 | K083202 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +1 | K023060 | Acculaser PRO4 | Acculaser, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 NHN? 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 NHN device
- #1 K241057 Enhanced Handheld Pain Relief Laser Instrument…score 12.9 · 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 |
|---|---|---|---|
| * | K010175 | Microlight 830 Laser System | 2002 |
What descends from it? (19)
See all 195 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?
How does its category compare?
All NHN devicesNHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHN
416in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHN
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHN
1in 2025
MAUDE reports naming product code NHN, 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 | 260 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 154 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 117 | 0 | 0 |
| 2019 | 2 | — | 2 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 416 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020657: Acculaser Pro Low Level Laser Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020657
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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