510(k) · Cleared
ClearedWS Frequency Spectrum Effect Physiatrics Apparatus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.A.I. Industries Corp. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on May 9, 1997 after a 585-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 152 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 585 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
152 later devices descend from it, 1 citing it directly.
- This deviceK954577 WS Frequency Spectrum Effect Physiatrics ApparatusC.A.I. Industries Corp. · 1997
- Descendant · cites it directly · 151 of its ownK013197 WS-501 Heat LampLhasa Medical, Inc. · 2002
- Descendant · 2 generations on · 150 of its ownK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- Descendant · 3 generations on · 128 of its ownK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- Descendant · 3 generations on · 127 of its ownK071872 VelashapeSyneron Medical, Ltd. · 2007
- Descendant · 3 generations on · 101 of its ownK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
Showing 5 of 152 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 152 · See all- K013197WS-501 Heat LampLhasa Medical, Inc. · 2002 · cites it directly151descendants
- K050397Velasmooth, ShaperSyneron Medical, Ltd. · 2005 · 2 generations on150descendants
- K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007 · 3 generations on128descendants
- K071872VelashapeSyneron Medical, Ltd. · 2007 · 3 generations on127descendants
- K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008 · 3 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954577 | WS Frequency Spectrum Effect Physiatrics Apparatus | C.A.I. Industries Corp. | 1997 | — |
| +1 | K013197 | WS-501 Heat Lamp | Lhasa Medical, Inc. | 2002 | — |
| +2 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| +3 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| +3 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| +3 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (152)
See all 1521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013197 | WS-501 Heat Lamp | 2002 | 151 |
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?
- Of its descendants, K013197 (Lhasa Medical, Inc., 2002) has gone furthest, with 151 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 | — |
https://510kreport.com/device/K954577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954577: WS Frequency Spectrum Effect Physiatrics Apparatus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954577
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026