510(k) · Cleared
ClearedTanda Restore, Model Ptscs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharos Life Corporation · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 15, 2009 as substantially equivalent to K070974 (Light Relief, LLC, 2007) and 2 other predicates after a 286-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Oct 15, 2009
- Review
- 286 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001179 (2000). 8 ancestors in all, the oldest K974468 (1998). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 1 generation backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- This deviceK090008 Tanda Restore, Model PtscsPharos Life Corporation · 2009
- Descendant · cites it directly · 3 of its ownK120582 HeatluxHome Skinovations, Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK150175 HeatLux Pro IHome Skinovations, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK112494 Varaya AR , Varaya SportVaraya Photoceuticals, LLC · 2012
- Descendant · cites it directly · 0 of its ownK162763 Vevazz LED Heat LampVevazz, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK152087 HeatLux Pro IIHome Skinovations, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120582HeatluxHome Skinovations, Ltd. · 2012 · cites it directly3descendants
- K150175HeatLux Pro IHome Skinovations, Ltd. · 2015 · 2 generations on1descendant
- K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC · 2012 · cites it directly1descendant
- K162763Vevazz LED Heat LampVevazz, LLC · 2017 · cites it directly0descendants
- K152087HeatLux Pro IIHome Skinovations, Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −1 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| 0 (this device) | K090008 | Tanda Restore, Model Ptscs | Pharos Life Corporation | 2009 | — |
| +1 | K120582 | Heatlux | Home Skinovations, Ltd. | 2012 | — |
| +2 | K150175 | HeatLux Pro I | Home Skinovations, Ltd. | 2015 | — |
| +1 | K112494 | Varaya AR , Varaya Sport | Varaya Photoceuticals, LLC | 2012 | — |
| +1 | K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017 | — |
| +3 | K152087 | HeatLux Pro II | Home Skinovations, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K070974 | Light Relief, Model LR150, LR200Summary page 2…Applicant 510(k) Number Date of FDA Device Name(s) Clearance Light Relief Pain Light Relief, LLC K070974 May 24, 2007 Relief Device MedX MedX Health Corp K020017 July 12, 2002 Quantum WARP… | 2007 |
| * | K020017 | Medx 1000 SeriesSummary page 2…Clearance Light Relief Pain Light Relief, LLC K070974 May 24, 2007 Relief Device MedX MedX Health Corp K020017 July 12, 2002 Quantum WARP Quantum Devices K032229 Nov 3, 2003 10 Light Delivery Syste… | 2002 |
| * | K032229 | Quantum Warp 10 Light Delivery SystemSummary page 2…, LLC K070974 May 24, 2007 Relief Device MedX MedX Health Corp K020017 July 12, 2002 Quantum WARP Quantum Devices K032229 Nov 3, 2003 10 Light Delivery System 6. Device Description The Tanda Restore is a modular platform which… | 2003 |
What descends from it? (6)
3 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 9 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K120582 (Home Skinovations, Ltd., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
T'inda Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090008 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090008: Tanda Restore, Model Ptscs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090008
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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