510(k) · Cleared
ClearedGuardian 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK110375 Blueshine's Gold SeriesBlueshine Srl · 2012
- This deviceK151629 Guardian 1000Quanta System Spa · 2015
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 3 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 2 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 1 generation backK110375 Blueshine's Gold SeriesBlueshine Srl · 2012
- This deviceK151629 Guardian 1000Quanta System Spa · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −1 | K110375 | Blueshine's Gold Series | Blueshine Srl | 2012 | — |
| 0 (this device) | K151629 | Guardian 1000 | Quanta System Spa | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 4 | 0 |
| 1993 | 7 | 0 |
| 1994 | 13 | 0 |
| 1995 | 14 | 0 |
| 1996 | 18 | 0 |
| 1997 | 19 | 0 |
| 1998 | 13 | 0 |
| 1999 | 8 | 0 |
| 2000 | 16 | 0 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 15 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110375 | Blueshine's Gold SeriesSummary 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)… | 2012 |
| * | K101893 | Nexus 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… | 2011 |
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 devicesGEX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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.
https://510kreport.com/device/K151629 · printed Nov 6, 2026
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