510(k) · Cleared
ClearedPrecision TDP, Heat and Infrared Lamps and Marvel and Wonder Lamps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prime Herbs Corporation · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jun 16, 2009 as substantially equivalent to K960036 (Helio Medical Supplies, Inc., 1996) and 3 other predicates after a 363-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Jun 16, 2009
- Review
- 363 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K890556 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK890556 TDP Infrared Heat LampToxicology Professionals, Inc. · 1989
- This deviceK081720 Precision TDP, Heat and Infrared Lamps and Marvel and Wonder LampsPrime Herbs Corporation · 2009
- Descendant · cites it directly · 0 of its ownK162590 Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162590Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890556 | TDP Infrared Heat Lamp | Toxicology Professionals, Inc. | 1989 | — |
| 0 (this device) | K081720 | Precision TDP, Heat and Infrared Lamps and Marvel and Wonder Lamps | Prime Herbs Corporation | 2009 | — |
| +1 | K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K960036 | Firard II/ TDP LampSummary page 1…nds of infrared heating lamps which have been found to be substantially equivalent through the 510(k) premarket notification process. These include the following: K960036 FIRARD II TDP Lamp Helio Medical Supplies, Inc K890556 TDP Infrared He… | 1996 |
| * | K890556 | TDP Infrared Heat LampSummary page 1…k) premarket notification process. These include the following: K960036 FIRARD II TDP Lamp Helio Medical Supplies, Inc K890556 TDP Infrared Heat Lamp Toxicology Professionals K991503 Sacred Crane TDP L… | 1989 |
| * | K991503 | Sacred Crane TDP Lamp, Models CQ-27, CQ-12, CQ-36Summary page 1…D II TDP Lamp Helio Medical Supplies, Inc K890556 TDP Infrared Heat Lamp Toxicology Professionals K991503 Sacred Crane TDP Lamp CQ27 United Pacific Co., K003528 TDP CQ-27 Heat Lamp… | 1999 |
| * | K003538 | TDP CQ-27 Heat Lamp Our reading of the summary gave K003528, FDA’s number for Sanarus Core Tissue Biopsy System (Endocare, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TDP CQ-27 Heat Lamp”. | 2001 |
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 |
|---|---|---|---|
| K162590 | Bashan TDP Heat Lamp | 2017 | 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?
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?
The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder 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, it 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/K081720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081720: Precision TDP, Heat and Infrared Lamps and Marvel and Wonder Lamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081720
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