510(k) · Cleared
ClearedDiolase 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 Feb 1, 2013 as substantially equivalent to K100558 (Quanta System Spa, 2010) and 1 other predicate after a 275-day review. Its family tree reaches back 18 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 275 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 381 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 1 generation backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- This deviceK121327 Diolase 10SBiolase Technology, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK131839 DC 7Dc International, LLC · 2013
- Descendant · cites it directly · 0 of its ownK130465 EPIC 10SBiolase Technology, Inc. · 2013
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 1 generation backK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- This deviceK121327 Diolase 10SBiolase Technology, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −1 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| 0 (this device) | K121327 | Diolase 10S | Biolase Technology, Inc. | 2013 | — |
| +1 | K131839 | DC 7 | Dc International, LLC | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K100558 | Quanta Diode Laser SystemSummary page 2…DtolaseM I 0S Expanded Indication for Use >3. PREDICATE DEVICES * (K 100558) Quanta System QUANTA Diode Laser Family by Quanta System SpA * (KI 10375) Blueshine GOLD Series by Blueshine sr]… | 2010 |
| * | K110375 | Blueshine's Gold Series | 2012 |
| † | K061898 | Ezlase | 2007 |
| † | K083069 | Ezlase 10W | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 months on median.
- 17 of the 381 ancestors have a recall of any class.
- Of its descendants, K131839 (Dc International, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K100558.
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?
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…
Read the full statement (600 words)
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 L and II
* Neck dissection
Arthroscopy:
Hemostasis, incision, excision, vaporization, and ablation of joint tissues during arthroscopic surgery, such as:
* Meniscectomy
* Synovectomy
* 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, Dematology & 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
* Herniorrhaphy
* 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 condylomnata acuminata
* Vaporization of CIN (cervical intraepithelial neoplasia)
* Cervical conization
* Menorrhagia
* Ovarian cystectomny
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:
Hemnostasis, vaporization, and excision of tissue, such as:
* Tracheolbronchial malignancy or stricture
* Benign and malignant pulmonary obstruction
Cardiac Surgery:
* Coagulation and hemnostasis 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, lymphangiomna and lymphangiomnatosis 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, 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, venulectasia 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/K121327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121327: Diolase 10S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121327
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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