510(k) · Cleared
ClearedLaser-D68
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laser Pain Clinics LP · GEX Powered Laser Surgical Instrument
Cleared on Dec 15, 2006 as substantially equivalent to K050070 (Eltech S.R.L, 2005) and 1 other predicate after a 189-day review. Its family tree reaches back 6 generations to 1988. 5 later devices descend from it.
- Decided
- Dec 15, 2006
- Review
- 189 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K875052 (1988). 27 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 5 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 4 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 3 generations backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- 2 generations backK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- 1 generation backK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- This deviceK061656 Laser-D68Laser Pain Clinics LP · 2006
- Descendant · cites it directly · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
- Descendant · 2 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK160947 LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR…Usa Laser Biotech, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK151521 Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K120604K-LaserEltech S.R.L · 2012 · cites it directly4descendants
- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 2 generations on0descendants
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
- K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
- K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −5 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −4 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −3 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| −2 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| −1 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K061656 | Laser-D68 | Laser Pain Clinics LP | 2006 | — |
| +1 | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| +2 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
| +2 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
| +2 | K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp… | Usa Laser Biotech, Inc. | 2016 | — |
| +2 | K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K050070 | K-Laser, Models 3,4,4D,6DSummary page 1…tion Panel: Physical Medicine III. Predicate Device Laser Pain Clinics is substantially equivalent to the Eltech s-r.[ K-Laser (K050070) and the Advanced Medical Technologies Maestro MDTL Laser System (K053473). The devices are therapeutic medical las… | 2005 |
| * | K053473 | Maestro MDTL Laser SystemSummary page 1…in Clinics is substantially equivalent to the Eltech s-r.[ K-Laser (K050070) and the Advanced Medical Technologies Maestro MDTL Laser System (K053473). The devices are therapeutic medical lasers designed to deliver light energy to the target tissue. IV.… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120604 | K-Laser | 2012 | 4 |
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 18 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K120604 (Eltech S.R.L, 2012) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K050070.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
Laser-D68 System provides visible red and infrared therapy to provide topical heating for
the temporary:
* Increase in local blood circulation
* Relief of minor muscles and joint aches, pains and stiffness
* Relaxation of muscles
* Relief of muscle spasms
* Relief of minor pain and stiffness associated with arthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061656 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061656: Laser-D68.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061656
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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