510(k) · Cleared
ClearedAcculaser PRO4
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 Mar 19, 2004 as substantially equivalent to K020657 (Acculaser, Inc., 2002) and 1 other predicate after a 553-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Mar 19, 2004
- Review
- 553 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010175 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
- 1 generation backK020657 Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002
- This deviceK023060 Acculaser PRO4Acculaser, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK043353 Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK072551 LD-I 75 and LD-I 200Meditech International, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| −1 | K020657 | Acculaser Pro Low Level Laser Therapy Device | Acculaser, Inc. | 2002 | — |
| 0 (this device) | K023060 | Acculaser PRO4 | Acculaser, Inc. | 2004 | — |
| +1 | K043353 | Omega Excel/XP Laser System | Advanced Medical Technologies, Inc. | 2005 | — |
| +2 | K072551 | LD-I 75 and LD-I 200 | Meditech International, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020657 | Acculaser Pro Low Level Laser Therapy DeviceSummary page 1…device Classification Name: Lamp. Non-heating, for Adjunctive Use in Pain Therapy 21 CFR 890.550; NHN Predicate Devices: K020657, Acculaser, Inc., AcculaSerTM Pro LLLT K01 01 75, MicroL-ight Corp., Microl-ight 830'-m Laser System… | 2002 |
| * | K010175 | Microlight 830 Laser SystemSummary page 1…n Pain Therapy 21 CFR 890.550; NHN Predicate Devices: K020657, Acculaser, Inc., AcculaSerTM Pro LLLT K01 01 75, MicroL-ight Corp., Microl-ight 830'-m Laser System KU1 258Cr TUCO Innovations, Inc_, TUCO Erchionia… | 2002 |
| Kept off the family tree | K012580 | FDA’s K012580 is Erchonia PL2000 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043353 | Omega Excel/XP Laser System | 2005 | 1 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K043353 (Advanced Medical Technologies, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K020657.
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 T" Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023060: Acculaser PRO4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023060
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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