510(k) Report

510(k) · Cleared

Cleared

The Life Vessel

K070690510(k) TraditionalCleared Nov 16, 2007248-day reviewClass II21 CFR 890.5500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cottonwood Vessel Corporation · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Nov 16, 2007 as substantially equivalent to K051681 (Care Electronics, Inc., 2005) and 3 other predicates after a 248-day review. Its family tree reaches back 11 generations to 1995.

Decided
Nov 16, 2007
Review
248 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
4

Its longest line of descent runs back 11 generations to K943450 (1995). 97 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 3 other ancestors2002: 5 other ancestors1998: 10 other ancestors2005: 1 other ancestor2004: 1 other ancestor1994: 9 other ancestors2000: 6 other ancestors2001: 1 other ancestor1999: 4 other ancestors1996: 12 other ancestors1995: 9 other ancestors1997: 13 other ancestors1993: 3 other ancestors1991: 3 other ancestors1990: 1 other ancestor1980: 1 other ancestor1992: 3 other ancestors1985: 1 other ancestorK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K022266 · Aurora SR · Syneron Medical, Ltd. · 2002K030426 · Omnilux Red · Photo Therapeutics Limited · 2003K043575 · Dermillume, Model PRO1000 · Care Electronics, Inc. · 2005K051681 · Dermillume Red, Model HR1000 · Care Electronics, Inc. · 2005198019851990199520002005
  1. Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 7 generations between
  3. 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
  4. 2 generations backK043575 Dermillume, Model PRO1000Care Electronics, Inc. · 2005
  5. 1 generation backK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
  6. This deviceK070690 The Life VesselCottonwood Vessel Corporation · 2007
Show all 11 generations
  1. Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
  9. 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
  10. 2 generations backK043575 Dermillume, Model PRO1000Care Electronics, Inc. · 2005
  11. 1 generation backK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
  12. This deviceK070690 The Life VesselCottonwood Vessel Corporation · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−10K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−9K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−8K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−7K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−6K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
−5K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
−4K022266Aurora SRSyneron Medical, Ltd.2002—
−3K030426Omnilux RedPhoto Therapeutics Limited2003—
−2K043575Dermillume, Model PRO1000Care Electronics, Inc.2005—
−1K051681Dermillume Red, Model HR1000Care Electronics, Inc.2005—
0 (this device)K070690The Life VesselCottonwood Vessel Corporation2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199010
199130
199230
199330
199490
199590
1996120
1997130
1998100
199940
200060
200110
200250
200330
200410
200510
FIG. 1 — Lineage of K070690, 1995–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K051681Dermillume Red, Model HR1000
Summary page 1
…Code: ILY 3. Predicate Devices The Life Vessel TM is substantially equivalent to a combination of the Care Electronics, Inc. Dermillume Red HRI000 Lamp (K051681), the Quantum Devices, Inc. Quantum WARP 10 Light Delivery System (K032229), the Diomedics, Inc. Pain-X-2000 Models:…
Care Electronics, Inc.2005—
*K032229Quantum Warp 10 Light Delivery System
Summary page 1
…ivalent to a combination of the Care Electronics, Inc. Dermillume Red HRI000 Lamp (K051681), the Quantum Devices, Inc. Quantum WARP 10 Light Delivery System (K032229), the Diomedics, Inc. Pain-X-2000 Models: 300, 600, 900, 1600, 2500 and 5700 (K982546), and the Light Force Therapy,…
Quantum Devices, Inc.2003—
*K982546Phaser-2000
Summary page 1
…the Quantum Devices, Inc. Quantum WARP 10 Light Delivery System (K032229), the Diomedics, Inc. Pain-X-2000 Models: 300, 600, 900, 1600, 2500 and 5700 (K982546), and the Light Force Therapy, Inc. Acubeam Super Nova, Dio (K022888). 4. Device Description The Life VesselTM i…
Diomedics, Inc.1998—
*K022888Acubeam, Super Nova, Dio
Summary page 1
…2229), the Diomedics, Inc. Pain-X-2000 Models: 300, 600, 900, 1600, 2500 and 5700 (K982546), and the Light Force Therapy, Inc. Acubeam Super Nova, Dio (K022888). 4. Device Description The Life VesselTM is a chamber in which the patient lays flat under the treatment light…
Light Force Therapy, Inc.2002—

Also cleared against K051681: 1 other device →

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 12 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 3 of the 97 ancestors have a recall of any class.
  • 1 other device also cites its predicate K051681.

How does its category compare?

All ILY devices

ILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · ILY

1in 2025

2007: 102008: 162009: 132010: 82011: 92012: 112013: 92014: 112015: 112016: 82017: 52020: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007: 128 days median2008: 165 days median2009: 189 days median2010: 185 days median2011: 198 days median2012: 130 days median2013: 211 days median2014: 153 days median2015: 146 days median2016: 214 days median2017: 116 days median
2007high 214 (2016) · low 116 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ILY

1in 2025

2010: 12012: 32022: 42023: 12025: 12026 (partial year): 1
2007high 4 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ILY

17in 2025

2007: 242008: 202009: 92010: 72011: 102012: 72013: 82015: 22016: 22017: 122018: 12019: 72020: 52021: 52022: 22023: 152024: 192025: 17
2007high 24 (2007) · low 0 (2014)2025

MAUDE reports naming product code ILY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710128024
200816165020
20091318909
2010818517
20119198010
20121113037
2013921108
20141115300
20151114602
2016821402
20175116012
20180—01
20190—07
20201—05
20210—05
20222—42
20231—115
20241—019
20251—117
20261—1—

What is it indicated for?

The Life VesselTM is indicated to provide topical heating for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stifffiess associated with arthritis, and to temporarily increase local blood circulation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K070690: The Life Vessel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070690

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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