510(k) · Cleared
ClearedLD-I 75 and LD-I 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech International, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Apr 2, 2008 as substantially equivalent to K010175 (Microlight Corporation of America, 2002) and 2 other predicates after a 205-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 2, 2008
- Review
- 205 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001179 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 3 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 2 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 1 generation backK043353 Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc. · 2005
- This deviceK072551 LD-I 75 and LD-I 200Meditech International, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −4 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −3 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −2 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −1 | K043353 | Omega Excel/XP Laser System | Advanced Medical Technologies, Inc. | 2005 | — |
| 0 (this device) | K072551 | LD-I 75 and LD-I 200 | Meditech International, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010175 | Microlight 830 Laser SystemSummary page 1…ication: Class II Establishment registration No.: Not applicable (foreign manufacture) Predicate Device: K010175, K043353, K050342 Trademark Notice: All Trademarks used other than those of Meditech International are registered to their respe… | 2002 |
| * | K043353 | Omega Excel/XP Laser SystemSummary page 1…Class II Establishment registration No.: Not applicable (foreign manufacture) Predicate Device: K010175, K043353, K050342 Trademark Notice: All Trademarks used other than those of Meditech International are registered to their respective own… | 2005 |
| * | K050342 | Theralase TLC-1000 Therapeutic Medical Laser SystemSummary page 1…Class II Establishment registration No.: Not applicable (foreign manufacture) Predicate Device: K010175, K043353, K050342 Trademark Notice: All Trademarks used other than those of Meditech International are registered to their respective owners. Conf… | 2005 |
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?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 10 ancestors has a recall.
- 10 other devices also cite its predicate K010175.
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. 2008, this device’s year, is highlighted.
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 LD-I-75 and LD-I-200 tm treatment heads are indicated for adjunctive use in the temporary relief of pain associated with rotator cuff tendonitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072551: LD-I 75 and LD-I 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072551
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