510(k) · Cleared
ClearedCell Gen Laser, Model CG-4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cell Gen Therapeutics, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Apr 21, 2008 as substantially equivalent to K032787 (Spectrum Laser & Technologies, 2003) after a 101-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Apr 21, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K875052 (1988). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 3 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 2 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 1 generation backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- This deviceK080084 Cell Gen Laser, Model CG-4000Cell Gen Therapeutics, LLC · 2008
- Descendant · cites it directly · 0 of its ownK213524 CytonPro-5000Cytonsys, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213524CytonPro-5000Cytonsys, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −3 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −2 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −1 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| 0 (this device) | K080084 | Cell Gen Laser, Model CG-4000 | Cell Gen Therapeutics, LLC | 2008 | — |
| +1 | K213524 | CytonPro-5000 | Cytonsys, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K032787 | Neurolase, Models 150V, 150C, 1064Summary page 1…. It also increases blood circulation and relaxes muscle tissue. IV. Predicate Device: a. Neurolase 150 - cleared under K032787 dated November 20, 2003 V. Device Description: The Cell Gen CG-4000 laser is… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213524 | CytonPro-5000 | 2022 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K213524 (Cytonsys, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032787.
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 model CG-4000 Cell Gen laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080084 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080084: Cell Gen Laser, Model CG-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080084
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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