510(k) · Cleared
ClearedIntermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedic Arfran, SA · GEX Powered Laser Surgical Instrument
Cleared on Sep 6, 2006 as substantially equivalent to K042211 (Surgical Laser Technologies, Inc., 2004) and 14 other predicates after a 260-day review. Its family tree reaches back 13 generations to 1995. 299 later devices descend from it.
- Decided
- Sep 6, 2006
- Review
- 260 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 13 generations to K943450 (1995). 160 ancestors in all, the oldest K800617 (1980). 299 later devices descend from it, 8 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- This deviceK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · cites it directly · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · cites it directly · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · cites it directly · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 2 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- This deviceK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
Showing 5 of 299 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 299 · See all- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · cites it directly263descendants
- K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly230descendants
- K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly229descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 2 generations on177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −8 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −7 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −6 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −5 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −1 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| 0 (this device) | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +1 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +1 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +1 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| +1 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +2 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 12 | 0 |
| 1996 | 14 | 0 |
| 1997 | 18 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 12 | 0 |
| 2022 | 25 | 0 |
| 2023 | 17 | 0 |
| 2024 | 30 | 0 |
| 2025 | 46 | 0 |
| 2026 | 24 | 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? (15)
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 |
|---|---|---|---|
| * | K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSummary page 7…Panel: 79 Class: II Predicate Device PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K0419… | 2004 |
| * | K040294 | Laserpro Diode Laser Systems, Models 810, 940 & 980Summary page 7…nel: 79 Class: II Predicate Device PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K0507… | 2004 |
| * | K031993 | Aurora SRSummary page 7…PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K0508… | 2003 |
| * | K050452 | Aurora SR and Sra ApplicatorSummary page 7…PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824)… | 2005 |
| * | K052324 | Polaris LV, Lva ApplicatorSummary page 7…toMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824)… | 2005 |
| * | K041969 | Aurora DSSummary page 7…980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Las… | 2004 |
| * | K041959 | Polaris DS/CometSummary page 7…Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System… | 2004 |
| * | K050796 | Aurora DS, DS ApplicatorSummary page 7…stems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864… | 2005 |
| * | K050824 | 100W Ceralas D 980 Laser System, Model D100Summary page 7…Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296)… | 2005 |
| * | K032864 | Ceralas D 810 Diode Laser System, Model D15Summary page 7…K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K00… | 2004 |
| * | K002296 | Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15Summary page 7…Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Sub… | 2000 |
| * | K021724 | Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas…Summary page 7…Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Di… | 2002 |
| * | K000072 | Dornier Medilas D SkinpulseSummary page 7…Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Diode Laser… | 2000 |
| * | K003993 | Dornier Medilas D Skinpulse Laser System (Skinpulse)Summary page 7…Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Diode Laser Family i… | 2001 |
| * | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Summary page 7…tem (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Diode Laser Family including Accessories have… | 2002 |
What descends from it? (299)
See all 2998 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072034 | Diode Medical Laser Family, Models 4, 6, 30 | 2007 | 263 |
| K071295 | 100W Ceralas D 980NM Diode Laser | 2007 | 230 |
| K072106 | 150W Ceralas D 980NM Diode Laser | 2007 | 229 |
| K083613 | Quanta System Polysurge Diode Laser Family | 2008 | 192 |
| K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode… | 2010 | 54 |
| K063396 | Velure Family of Diode Lasers and Delivery Device Accessories | 2007 | 22 |
| K093087 | BWF-5 Medical Laser Series | 2010 | 0 |
| K091323 | Modified Intermedic Diode Laser 980NM System (Multidiode SST 200) | 2009 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 160 ancestors have a recall of any class.
- Of its descendants, K072034 (Quanta System Spa, 2007) has gone furthest, with 263 descendants of its own.
- 2 other devices also cite its predicate K042211.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including…
Read the full statement (512 words)
The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
Examples include:
» LASER 810nm and 980nm
Urology:
• Lesions of external genitalia
• Circumcision
• Condyloma
• Bladder tumors
• Bladder neck incisions
• Vaporization of the prostate
• Hepatobiliary tumors
General Surgery:
• Rectal an anal hemorrhoidectomy
• Mastectomy
• Dermabrasion
• Appendectomy (open and laparoscopic)
• Bowel resection (open and laparoscopic)
• Colectomy
• Liver resection
• Resections of organs
• Thyriodectomy
• Adhesiolysis
• Thoracotomy
• Cholecystectomy (open and laparoscopic)
• Condyloma
• Breast biopsy
Neurosurgery:
• Percutaneous Disc Decompression
• Discectomy
• Hemostasis in conjunction with meningiomas
Gynecology:
• Cervical conization
• Myomectomy
• Endometrial ablation
• Ovarian cystectomy
• Appendectomy
Ophthalmology:
• Dacryocystorhinostomy transcanalicular
• Open DCR
• Tumor excision
• Blepharoplasty
Orthopedics:
• Dissect and coagulate
Gastroenterology:
• Hemostasis of colonoscopy
• Hemostasis of esophageal varices
• Excision of polyps
Arthroscopy:
• Chondromalacia
• Synovectomy
• Menisectomy
Thoracic Surgery:
• Thoracotomy
• Pulmonary resection
• Hemostasis
• Pericardiectomy
• Adhesiolysis
• Coagulation of blebs and bullae
Pulmonology:
• Endoscopic pulmonary applications
• Tracheal bronchial lesions
• Benign an malignant pulmonary obstruction
Otolaryngology ENT:
• Removal of benign lesions from the ear, nose and throat
• Excision of carcinoma of the larynx
• Incision and excision of carcinoma in situ
• Neck dissection
• Laryngeal papillomectomy
• Removal of vocal cord/fold nodules, polyps and cysts
Dental applications:
• Frenectomy
• Frenotomy
• Biopsy
• Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening
Pulmonary Surgery:
• Endoscopic pulmonary applications
• Tracheal bronchial lesions
• Benign and malignant pulmonary or stricture
Cardiac Surgery:
• Coagulation and hemostasis of cardiac tissue
Dermatology/Aesthetics:
• Photocoagulation of vascular & dermatological lesions of the face and extremities
• Photocoagulation of telangiectasia, veinulectasias of the legs and face
• Treatment of reticular veins and branch varicosities
• Pyogenic granuloma, lymphangioma and lymphagiomatosis disease, angiofibromas.
• Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, 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 basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment.
Seborrheic keratosis
Mixoid cyst
Papillary varix
Acne treatment
Hair removal of unwanted hair from skin type I-V
Plastic Surgery:
• Cut, coagulation & vaporization
• Resurfacing non
• Blepharoplasty
Vascular Surgery:
• Endoluminal or endovenous laser surgery for saphenous incompetent veins
» ContrAge RF
Dermatology/Aesthetics:
Non invasive treatment of wrinkles and rhytids
Non invasive scar reduction treatment (acne or traumatic scars)
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/K053540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053540
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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