510(k) · Cleared
ClearedThe Time Machine Series Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Lasers Manufacturer, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 8, 2016 as substantially equivalent to K122567 (Sciton, Inc, 2013) after a 315-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Jul 8, 2016
- Review
- 315 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K943450 (1995). 414 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- 2 generations backK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- 1 generation backK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- This deviceK152461 The Time Machine Series LasersMedical Lasers Manufacturer, Inc. · 2016
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- 3 generations backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- 2 generations backK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- 1 generation backK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- This deviceK152461 The Time Machine Series LasersMedical Lasers Manufacturer, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| −3 | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| −2 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| −1 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| 0 (this device) | K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 25 | 0 |
| 1997 | 30 | 0 |
| 1998 | 27 | 0 |
| 1999 | 22 | 0 |
| 2000 | 31 | 0 |
| 2001 | 34 | 0 |
| 2002 | 40 | 0 |
| 2003 | 34 | 0 |
| 2004 | 24 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 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 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 |
|---|---|---|---|
| * | K122567 | Joule 810/940/980 Multi-Platform SystemSummary page 4…cine 5. Predicate Device: The Time Machine Series Lasers device is substantially equivalent to the Joule 810/940/980 Multi-Platform System by Sciton, Inc. (K122567). 6. Device Description The TTML-8102000 hand held laser device operates in continuous wave mode at a fixed frequency. Th… | 2013 |
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 21 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 19 of the 414 ancestors have a recall of any class.
- 2 other devices also cite its predicate K122567.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Time Machine Series Lasers Model TTML-8102000 - 810/830 nm is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152461: The Time Machine Series Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152461
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