510(k) · Cleared
ClearedOmega Excel/XP Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technologies, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Jul 1, 2005 as substantially equivalent to K023060 (Acculaser, Inc., 2004) and 1 other predicate after a 207-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jul 1, 2005
- Review
- 207 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001179 (2000). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 2 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 1 generation backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- This deviceK043353 Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK072551 LD-I 75 and LD-I 200Meditech International, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072551LD-I 75 and LD-I 200Meditech International, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −3 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −2 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −1 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| 0 (this device) | K043353 | Omega Excel/XP Laser System | Advanced Medical Technologies, Inc. | 2005 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K023060 | Acculaser PRO4Summary page 2…ted with rotator cuff tendonitis. IV. Predicate Devices Predicate devices to the Omega Xp Laser System are the Photo Thera, Inc. Acculaser Pro 4 (K023060) and the Stargate International, Inc. Excalibur Ught Therapy System (K041530). V. Summary of the Technical Characteris… | 2004 |
| * | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001Summary page 2…evices to the Omega Xp Laser System are the Photo Thera, Inc. Acculaser Pro 4 (K023060) and the Stargate International, Inc. Excalibur Ught Therapy System (K041530). V. Summary of the Technical Characteristics of the Omega XP Laser System as Related to the Referenced Predicate Devi… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072551 | LD-I 75 and LD-I 200 | 2008 | 0 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K072551 (Meditech International, Inc., 2008) 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 Omega Xp Laser System is intended for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043353: Omega Excel/XP Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043353
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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