510(k) · Cleared
ClearedSoftcure 96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellray Medical Laser, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on May 5, 2017 as substantially equivalent to K051816 (Biocare Systems, Inc., 2005) and 3 other predicates after a 116-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- May 5, 2017
- Review
- 116 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K943450 (1995). 142 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 2 generations backK122237 Biophotas LifelightBiophotas, Inc. · 2013
- 1 generation backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- This deviceK170068 Softcure 96Wellray Medical Laser, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 5 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 4 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 3 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 2 generations backK122237 Biophotas LifelightBiophotas, Inc. · 2013
- 1 generation backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- This deviceK170068 Softcure 96Wellray Medical Laser, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −5 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −4 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −3 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −2 | K122237 | Biophotas Lifelight | Biophotas, Inc. | 2013 | — |
| −1 | K131113 | Biophotas Celluma | Biophotas, Inc. | 2014 | — |
| 0 (this device) | K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K051816 | Lumiwave 1X4 Infrared Therapy DeviceSummary page 4…tcure™ 96 Common/Usual Name: Infrared Therapeutic Heating Lamp Classification Name: Infrared Lamp C. Predicate Devices Biocare TM Lumiwave® K051816 Sunetics Laser Brush, LHB 12 K121920 Anodyne® Therapy 480 Pro K931261 Biophotas Celluma TM K131113 D. Device Description: The Wel… | 2005 |
| * | K121920 | LaserbrushSummary page 4…Infrared Therapeutic Heating Lamp Classification Name: Infrared Lamp C. Predicate Devices Biocare TM Lumiwave® K051816 Sunetics Laser Brush, LHB 12 K121920 Anodyne® Therapy 480 Pro K931261 Biophotas Celluma TM K131113 D. Device Description: The Wellray® Medical Laser SoftcureTM 96 is… | 2013 |
| * | K931261 | Spectropad SystemSummary page 4…ing Lamp Classification Name: Infrared Lamp C. Predicate Devices Biocare TM Lumiwave® K051816 Sunetics Laser Brush, LHB 12 K121920 Anodyne® Therapy 480 Pro K931261 Biophotas Celluma TM K131113 D. Device Description: The Wellray® Medical Laser SoftcureTM 96 is a therapeutic device using wavele… | 1994 |
| * | K131113 | Biophotas CellumaSummary page 4…Infrared Lamp C. Predicate Devices Biocare TM Lumiwave® K051816 Sunetics Laser Brush, LHB 12 K121920 Anodyne® Therapy 480 Pro K931261 Biophotas Celluma TM K131113 D. Device Description: The Wellray® Medical Laser SoftcureTM 96 is a therapeutic device using wavelengths of monochromatic light… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 142 ancestors have a recall of any class.
- 2 other devices also cite its predicate K051816.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Softcure TM 96 is intended to emit energy in the visible spectrum (red 635nm) to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170068: Softcure 96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170068
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