510(k) · Cleared
ClearedMedx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medx Electronics, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 1, 2008 as substantially equivalent to K032231 (Medx Electronics, Inc., 2003) after a 15-day review. Its family tree reaches back 3 generations to 2000. 59 later devices descend from it.
- Decided
- Oct 1, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001179 (2000). 59 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 1 generation backK032231 MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx…Medx Electronics, Inc. · 2003
- This deviceK082707 Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc. · 2008
- Descendant · cites it directly · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
- Descendant · 2 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · 2 generations on · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · 3 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · 3 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K083595EzlaseBiolase Technology, Inc. · 2009 · cites it directly58descendants
- K121286EPIC 10Biolase Technology, Inc. · 2012 · 2 generations on31descendants
- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · 2 generations on25descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · 3 generations on21descendants
- K150724SculpSureCynosure, Inc. · 2015 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −2 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −1 | K032231 | MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable… | Medx Electronics, Inc. | 2003 | — |
| 0 (this device) | K082707 | Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser | Medx Electronics, Inc. | 2008 | — |
| +1 | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
| +2 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +2 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +3 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +3 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K032231 | MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable LaserSummary page 1…edicine Device, 21 CFR 890.5500 (Class II) Predicate Devices: MedX 1100 Console, LCS 100 Portable Laser and LCT 100 Tethered Laser (K032231) This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CF… | 2003 |
What descends from it? (59)
See all 592 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083595 (Biolase Technology, Inc., 2009) has gone furthest, with 58 descendants of its own.
- 2 other devices also cite its predicate K032231.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The MedX LPT 200 single diode tethered laser is a part of the infrared console systern, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis. The MedX LPS 200 single diode Portable Laser is a rechargeable infrared device, as…
Read the full statement (119 words)
The MedX LPT 200 single diode tethered laser is a part of the infrared console systern, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
The MedX LPS 200 single diode Portable Laser is a rechargeable infrared device, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082707: Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082707
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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