510(k) · Cleared
ClearedTheralase TLC-1000 Therapeutic Medical Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theralase, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Jul 11, 2005 after a 150-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jul 11, 2005
- Review
- 150 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK050342 Theralase TLC-1000 Therapeutic Medical Laser SystemTheralase, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK081166 Lightstream Low Level LaserSolica Corporation · 2009
- Descendant · cites it directly · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K050342 | Theralase TLC-1000 Therapeutic Medical Laser System | Theralase, Inc. | 2005 | — |
| +1 | K081166 | Lightstream Low Level Laser | Solica Corporation | 2009 | — |
| +1 | K072551 | LD-I 75 and LD-I 200 | Meditech International, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 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, K081166 (Solica Corporation, 2009) has gone furthest, with 0 descendants of its own.
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 Theralase T M TLC-1 000 Therapeutic Medical Laser System is indicated for
adjunctive use in the temporary relief of pain associated with knee disorders with
standard chiropractic practice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050342: Theralase TLC-1000 Therapeutic Medical Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050342
Report an extraction error
Are you the manufacturer?
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