510(k) · Cleared
ClearedWS-501 Heat Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lhasa Medical, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Aug 29, 2002 as substantially equivalent to K954577 (C.A.I. Industries Corp., 1997) and 2 other predicates after a 338-day review. Its family tree reaches back 1 generation to 1996. 151 later devices descend from it.
- Decided
- Aug 29, 2002
- Review
- 338 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K960036 (1996). 3 ancestors in all. 151 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960036 Firard II/ TDP LampHelio Medical Supplies, Inc. · 1996
- This deviceK013197 WS-501 Heat LampLhasa Medical, Inc. · 2002
- Descendant · cites it directly · 150 of its ownK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- Descendant · 2 generations on · 128 of its ownK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- Descendant · 2 generations on · 127 of its ownK071872 VelashapeSyneron Medical, Ltd. · 2007
- Descendant · 2 generations on · 101 of its ownK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- Descendant · 2 generations on · 95 of its ownK053611 SmoothshapesBicellulase, Inc. · 2006
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 151 · See all- K050397Velasmooth, ShaperSyneron Medical, Ltd. · 2005 · cites it directly150descendants
- K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007 · 2 generations on128descendants
- K071872VelashapeSyneron Medical, Ltd. · 2007 · 2 generations on127descendants
- K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008 · 2 generations on101descendants
- K053611SmoothshapesBicellulase, Inc. · 2006 · 2 generations on95descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960036 | Firard II/ TDP Lamp | Helio Medical Supplies, Inc. | 1996 | — |
| 0 (this device) | K013197 | WS-501 Heat Lamp | Lhasa Medical, Inc. | 2002 | — |
| +1 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| +2 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| +2 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| +2 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| +2 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 14 | 0 |
| 2017 | 10 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 12 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K954577 | WS Frequency Spectrum Effect Physiatrics ApparatusSummary page 2…ntially equivalent through the 5 10(k) premarket notification process. These include the following: WS Portable Infrared Heat Lamp, CAI Industries, 510k # K-954577 TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538 Firard I1 TDP Lamp, Helio Medical Supplies, 510k #:… | 1997 |
| * | K003538 | TDP CQ-27 Heat LampSummary page 2…rocess. These include the following: WS Portable Infrared Heat Lamp, CAI Industries, 510k # K-954577 TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538 Firard I1 TDP Lamp, Helio Medical Supplies, 510k #: K-960036 ( 4 (4) Description of the WS-501 Heat Lamp.… | 2001 |
| * | K960036 | Firard II/ TDP LampSummary page 2…Lamp, CAI Industries, 510k # K-954577 TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538 Firard I1 TDP Lamp, Helio Medical Supplies, 510k #: K-960036 ( 4 (4) Description of the WS-501 Heat Lamp. The WS-501 Heat Lamp is used to provide topical heating to the body. Th… | 1996 |
What descends from it? (151)
See all 1511 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050397 | Velasmooth, Shaper | 2005 | 150 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K050397 (Syneron Medical, Ltd., 2005) has gone furthest, with 150 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.
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 WS-501 Heat Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the WS-501 Heat Lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013197: WS-501 Heat Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013197
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026