510(k) Report

510(k) · Cleared

Cleared

Guardian 1000

K151629510(k) TraditionalCleared Oct 27, 2015132-day reviewClass II21 CFR 878.4810

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

Quanta System Spa · GEX Powered Laser Surgical Instrument

Cleared on Oct 27, 2015 as substantially equivalent to K110375 (Blueshine Srl, 2012) and 1 other predicate after a 132-day review. Its family tree reaches back 16 generations to 1995.

Decided
Oct 27, 2015
Review
132 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
2

Its longest line of descent runs back 16 generations to K943450 (1995). 211 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 3 other ancestors2008: 1 other ancestor2005: 6 other ancestors2004: 9 other ancestors2007: 1 other ancestor2006: 1 other ancestor2003: 15 other ancestors2002: 17 other ancestors2000: 16 other ancestors2001: 15 other ancestors1998: 13 other ancestors1995: 14 other ancestors1999: 8 other ancestors1997: 19 other ancestors1996: 18 other ancestors1994: 13 other ancestors1993: 7 other ancestors1992: 4 other ancestors1991: 6 other ancestors1990: 2 other ancestors1989: 2 other ancestors1985: 1 other ancestor1980: 1 other ancestor1986: 1 other ancestorK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K072034 · Diode Medical Laser Family, Models 4, 6, 30 · Quanta System Spa · 2007K110375 · Blueshine's Gold Series · Blueshine Srl · 20121980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 10 other ancestors4 generations back: 24 other ancestors5 generations back: 20 other ancestors6 generations back: 43 other ancestors7 generations back: 37 other ancestors8 generations back: 24 other ancestors9 generations back: 26 other ancestors10 generations back: 3 other ancestors11 generations back: 2 other ancestors K110375 · Blueshine's Gold Series · Blueshine Srl · 2012K072034 · Diode Medical Laser Family, Models 4, 6, 30 · Quanta System Spa · 2007K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50
  1. Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 12 generations between
  3. 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  4. 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  5. 1 generation backK110375 Blueshine's Gold SeriesBlueshine Srl · 2012
  6. This deviceK151629 Guardian 1000Quanta System Spa · 2015
Show all 16 generations
  1. Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  16. 1 generation backK110375 Blueshine's Gold SeriesBlueshine Srl · 2012
  17. This deviceK151629 Guardian 1000Quanta System Spa · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−15K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−14K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−13K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−12K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−11K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−10K000944Thermage Thermacool SystemThermage, Inc.2000—
−9K013034Modification to: Thermacool IiaThermage, Inc.2001—
−8K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−7K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−6K030142Thermacool TC SystemThermage, Inc.2003—
−5K031671Polaris WRSyneron Medical, Ltd.2003—
−4K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−3K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−2K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007—
−1K110375Blueshine's Gold SeriesBlueshine Srl2012—
0 (this device)K151629Guardian 1000Quanta System Spa2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198610
198920
199020
199160
199240
199370
1994130
1995140
1996180
1997190
1998130
199980
2000160
2001150
2002170
2003150
200490
200560
200610
200710
200810
200930
201010
201110
FIG. 1 — Lineage of K151629, 1995–2015Source: 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 GEX? 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 GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K110375Blueshine's Gold Series
Summary page 5
…Code: GEX, ILY, PDZ Predicate Devices: Guardian 1000 is substantially equivalent to the following legally marketed predicate devices:  K110375 Gold Series - Blueshine srl (Italy)  K101893 Nexus 30- USA Laser Biotech Inc. (USA)…
Blueshine Srl2012—
*K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…
Summary page 5
…icate Devices: Guardian 1000 is substantially equivalent to the following legally marketed predicate devices:  K110375 Gold Series - Blueshine srl (Italy)  K101893 Nexus 30- USA Laser Biotech Inc. (USA) 5-1…
Usa Laser Biotech, Inc.2011—

Also cleared against K110375: 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 20 years and passes through 6 companies; a new generation was cleared every 11 months on median.
  • 8 of the 211 ancestors have a recall of any class.
  • 1 other device also cites its predicate K110375.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle. Guardian 1000 with its delivery accessories is indicated for use in…

Read the full statement (419 words)

Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide

topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and

stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary

relaxation of muscle.

Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation,

vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology,

neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, pulmonology,

ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.

Gastroenterology

Hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms;

hemostasis in colonoscopy.

Neurosurgery

Tumors adjacent to the spinal cord; tumors adjacent to the cortex.

General Surgery

Ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open

procedures. Applications include but are not limited to: Laparoscopic: appendectomy, cholecystectomy, bowel resection.

Open: mastectomy, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, bowel resection,

colectomy, cholecystectomy, liver resection, condyloma, thyroidectomy, thoracotomy; cavernous hemangioma.

Genitourinary (Urology)

Transurethral: transurethral incision of the prostate (TUIP), bladder tumors, bladder neck incisions, urethral strictures,

exterior sphincterotomy, laparoscopic lymphadenectomy. Open: condyloma, circumcision, benign and malignant lesions

of external genitalia.

Thoracic Surgery

Pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectomy, mediastinal and thoracic lesions and

abnormalities, mediastinal lymph node dissection, hemostasis; thoracotomy.

Gynecology (GYN)

Laparoscopic excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted

hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy, ovarian drilling,

tubal fimbrioplasty, appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN),

vulvar and vaginal intraepithelial neoplasia VIN, VAIN, condyloma acuminata, including cervical, genital, vulvar,

perineal, and Bowen's disease, (Erithroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/

polyps/adhesions; Resection of septum.

Pulmonology

Tracheal bronchial lesions.

Ophthalmology

Oculoplastics, open DCR, endo-nasal DCR, tumor excision and biopsy, eyelid reconstruction; blepharoplasty.

Orthopedics

Dissect and coagulate.

Otolaryngology (ENT)

Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy;

meatal antrostomy;

Laryngo-tracheal: removal of vocal cord/ fold nodules, polyps and cysts; arytenoidectomy; tracheal stenosis;

Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and

tonsil; hemi glossectomy;

Head & Neck: tumor resection on oral, sub facial and neck tissues; parathyroidectomy; thyroidectomy.

Podiatry

Matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T

mentagrophytes, and /or yeasts Candida albicans, etc.).

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K151629: Guardian 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151629

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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