510(k) · Cleared
ClearedEPIC 10S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 11, 2013 as substantially equivalent to K121327 (Biolase Technology, Inc., 2013) after a 45-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Apr 11, 2013
- Review
- 45 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K943450 (1995). 382 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 2 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 1 generation backK121327 Diolase 10SBiolase Technology, Inc. · 2013
- This deviceK130465 EPIC 10SBiolase Technology, Inc. · 2013
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 2 generations backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- 1 generation backK121327 Diolase 10SBiolase Technology, Inc. · 2013
- This deviceK130465 EPIC 10SBiolase Technology, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −2 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| −1 | K121327 | Diolase 10S | Biolase Technology, Inc. | 2013 | — |
| 0 (this device) | K130465 | EPIC 10S | Biolase Technology, Inc. | 2013 | — |
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 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 8 | 0 |
| 1992 | 6 | 0 |
| 1993 | 11 | 0 |
| 1994 | 22 | 0 |
| 1995 | 19 | 0 |
| 1996 | 25 | 0 |
| 1997 | 29 | 0 |
| 1998 | 29 | 0 |
| 1999 | 19 | 0 |
| 2000 | 29 | 0 |
| 2001 | 32 | 0 |
| 2002 | 36 | 0 |
| 2003 | 30 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K121327 | Diolase 10SSummary page 4…ticular veins and branch varicosities Summary of Technological Characteristics Descriptive EpkIc10 Diolase 105 (K121327) Information III Company Biolase Technology, Inc. Biolase Technology, Inc. Biol… | 2013 |
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 18 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 17 of the 382 ancestors have a recall of any class.
- 1 other device also cites its predicate K121327.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity such as: * Removal of benign lesions from ear, nose and throat * Excision and…
Read the full statement (632 words)
The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use:
Ear, Nose and Throat and Oral Surgery:
Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity such as:
* Removal of benign lesions from ear, nose and throat
* Excision and vaporization of vocal cord nodules and polyps
* Incision and excision of carcinoma in-situ
* Ablation and vaporization of hyperkeratosis
* Laryngeal papillectomy
* Excision and vaporization of herpes simplex I and II
* Neck dissection
Arthroscopy:
Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery, such as:
* Menisectomy
* Syovectomy
* Chondromalacia
Gastroenterology:
Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy, such as:
* Hemostasis of upper and lower GI bleeding
* Excision and vaporization of colorectal carcinoma
* Excision of polyps
* Hemostasis of colonoscopy
* Hemostasis of esophageal varices
Orthopedics:
* Dissect and coagulate
General Surgery, Dermatology & Plastic Surgery, and Podiatry:
Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
* Matrixectomy
* Excision of neuromas
* Excision of periungual and subungual warts
* Excision of plantar warts
* Excision of Keloids
* Excision of cutaneous lesions
* Hemorrhoidectomy
* Appendectomy
* Debridement of decubitus ulcer
* Hepatobiliary
* Mastectomy
* Dermabrasion
* Vaporization & hemostasis of capillary hemangioma
* Excision, vaporization & hemostasis of abdominal tumors
* Excision, vaporization & hemostasis of rectal pathology
* Pilonidal cystectomy
* Herniorraphy
* Adhesiolysis
* Parathyroidectomy
* Laparoscopic cholecystecomy
* Thyroidectomy
* Resection of organs
GI/GU:
Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as:
* Hemorrhoidectomy
* Excision, vaporization, and hemostasis of rectal pathology
* Excision, vaporization, and hemostasis of abdominal tumors
Gynecology:
Ablation, excision, hemostasis, and vaporization of tissue, such as:
* Excision or vaporization of condylomata acuminata
* Vaporization of CIN (cervical intraepithelial neoplasia)
* Cervical conization
* Menorrhagia
* Ovarian cystectomy
Neurosurgery:
Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as:
* Hemostasis in conjunction with meningiomas
* Percutaneous Disc Decompression (PLDD)
Ophthalmology:
* Dacryocystorhinostomy transcanalicular
* Open DCR
* Tumor Excision
* Blepharoplasty
Pulmonary Surgery:
Hemostasis, vaporization, and excision of tissue, such as:
* Tracheobronchial malignancy or stricture
* Benign and malignant pulmonary obstruction
Cardiac Surgery:
* Coagulation and hemostasis of cardiac tissue
Thoracic Surgery:
* Thoracotomy
* Pulmonary resection
* Hemostasis
* Pericardiectomy
* Adhesiolysis
* Coagulation of blebs and bullae
Urology:
Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as:
* Vaporization of urethral tumors
* Release of urethral stricture
* Removal of bladder neck obstruction
* Excision and vaporization of condyloma
* Lesions of external genitalia
* Circumcision
* Vaporization of the prostate to treat benign prostate hyperplasia (BPH)
Dermatology/Aesthetics:
* Photocoagulation of vascular & dermatological lesions of the face and extremities
* Photocoagulation of telangiectasia, venulectasia of the legs and face
* Treatment of reticular veins and branch varicosities
* Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
* Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi
* Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe and Kaposi sarcoma, warty leucoplasty and ulcers debridement
* Seborrheic keratosis
* Mixoid cyst
* Papillary varix
* Acne treatment
Vascular Surgery:
* Photocoagulation of vascular & dermatological lesions of the face and extremities
* Photocoagulation of telangiectasia, veinulectasia of the legs and face
* Treatment of reticular veins and branch varicosities
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130465: EPIC 10S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130465
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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