510(k) · Cleared
ClearedOpera Evo
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 15, 2020 as substantially equivalent to K133891 (Asclepion Laser Technologies GmbH, 2015) after an 84-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Oct 15, 2020
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K943450 (1995). 340 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 2 generations backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- 1 generation backK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- This deviceK202041 Opera EvoQuanta System Spa · 2020
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 8 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 7 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 4 generations backK100726 Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM…Biolitec, Inc. · 2010
- 3 generations backK112013 Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc. · 2012
- 2 generations backK120231 Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc. · 2012
- 1 generation backK133891 Multipulse TM+1470Asclepion Laser Technologies GmbH · 2015
- This deviceK202041 Opera EvoQuanta System Spa · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −8 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −7 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −4 | K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM… | Biolitec, Inc. | 2010 | — |
| −3 | K112013 | Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser | Biolitec, Inc. | 2012 | — |
| −2 | K120231 | Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) | Biolitec Medical Devices, Inc. | 2012 | — |
| −1 | K133891 | Multipulse TM+1470 | Asclepion Laser Technologies GmbH | 2015 | — |
| 0 (this device) | K202041 | Opera Evo | Quanta System Spa | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 26 | 0 |
| 1998 | 22 | 0 |
| 1999 | 17 | 0 |
| 2000 | 27 | 0 |
| 2001 | 29 | 0 |
| 2002 | 33 | 0 |
| 2003 | 28 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K133891 | Multipulse TM+1470Summary page 6…e: GEX Predicate Device MultiPulse TM+1470 – Asclepion Laser Technologies Gmbh (K133891) Description of the device: The Opera Evo laser device includes a diode laser that emits a wavelength of 1940 nm and includes a… | 2015 |
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 25 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 17 of the 340 ancestors have a recall of any class.
- 2 other devices also cite its predicate K133891.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Opera Evo laser device and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical Traditionalties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery and Arthroscopy. Urology: Open and endoscopic surgery (incision, excision, resection…
Read the full statement (471 words)
Opera Evo laser device and its fibre optic delivery system are intended for use in surgical procedures
using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis
of soft tissue in use in medical Traditionalties including: Urology, Gastroenterology, Thoracic and Pulmonary,
Gynecology, ENT, General Surgery and Arthroscopy.
Urology:
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
• Urethral Strictures
• Bladder Neck Incisions (BNI)
• Ablation and Resection of Bladder Tumors, Urethral and Ureteral Tumors
• Ablation of Benign Prostatic Hypertrophy (BPH)
• Transurethral Incision of the Prostate (TUIP)
• Laser Resection of the Prostate
• Laser Enucleation of the Prostate
• Laser Ablation of the Prostate
• Condylomas
• Lesions of external genitalia
ENT:
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft
tissue) including:
• Endonasal/sinus Surgery
• Partial turbinectomy
• Polypectomy
• Dacryocystorhinostomy
• Frontal sinusotomy
• Ethmoidectomy
• Maxillary antrostomy
• Functionale endoscopic sinus surgery
• Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal area
• Tonsillectomy
• Adenoidectomy
Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and
hemostasis) including:
• Polyps
• Biopsy
• Gall Bladder calculi
• Biliary/Bile duct calculi
• Ulcers
• Gastric ulcers
• Duodenal ulcers
• Non-bleeding ulcers
• Pancreatitis
• Hemorrhoids
• Cholecystectomy
• Benign and Malignant Neoplasm
• Angiodysplasia
• Colorectal cancer
• Telangiectasias
• Telangiectasias of the Osler-Weber-Rendu disease (OWRD)
• Vascular Malformation
• Gastritis
• Esophagitis
• Esophageal ulcers
• Varices
• Colitis
• Mallory-Weiss tear
• Gastric erosion
Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation
and hemostasis) of soft tissue including:
• Laryngeal lesions
Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and
hemostasis) including:
• Intra-uterine treatment of submucous fibroids
• Benign endometrial polyps and uterine septum by incision, excision, ablation and vessel coagulation
• Soft tissue excision procedures such as excisional conization of the cervix
General Surgery:
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and
hemostasis) including:
• Cholecystectomy
• Lysis of adhesion
• Appendectomy
• Biopsy
• Skin incision
• Tissue dissection
• Excision of external tumors and lesions
• Complete or partial resection of internal organs, tumors and lesions
• Mastectomy
• Hepatectomy
• Pancreatectomy
• Splenectomy
• Thyroidectomy
• Parathyroidectomy
• Herniorrhaphy
• Tonsillectomy
• Lymphadenectomy
• Partial Nephrectomy
• Pilonidal Cystectomy
• Resection of lipoma
• Debridement of Decubitus Ulcer
• Hemorrhoids
• Debridement of Statis Ulcer
Arthroscopy:
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
Ablation of soft, cartilaginous and bony tissue in Minimal invasive Spinal Surgery including:
• Percutaneous Laser Disc Decompression/Discectomy
• Foraminoplasty
• Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasi ve spinal surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202041 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202041: Opera Evo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202041
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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