510(k) · Cleared
ClearedModified Intermedic Diode Laser 980NM System (Multidiode SST 200)
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 Jun 4, 2009 as substantially equivalent to K053540 (Intermedic Arfran, SA, 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Jun 4, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 168 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- This deviceK091323 Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA · 2009
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- This deviceK091323 Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| 0 (this device) | K091323 | Modified Intermedic Diode Laser 980NM System (Multidiode SST 200) | Intermedic Arfran, SA | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 18 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Summary page 1…Laser Powered Surgical Instruments (and accessories) III. Predicate Devices * INTERmedic Arfran, S.A. -:INTERmedic Diode Laser Diode Family (K053540) * Biolitec, Inc. - 180W Ceralas D 980nm Diode Laser (Model D180) (K083682) IV. Product Description The modi… | 2006 |
| * | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180Summary page 1…icate Devices * INTERmedic Arfran, S.A. -:INTERmedic Diode Laser Diode Family (K053540) * Biolitec, Inc. - 180W Ceralas D 980nm Diode Laser (Model D180) (K083682) IV. Product Description The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180), and the deli… | 2009 |
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 14 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 7 of the 168 ancestors have a recall of any class.
- 7 other devices also cite its predicate K053540.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is 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…
Read the full statement (500 words)
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is 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 980 nm
Urology:
-. Lesions of external genitalia
* Circumcision
* Condyloma
* Bladder tumors
* Bladder neck incisions
* Vaporization of the prostate.
Laser 980 nm
General Surgery:
* Rectal and anal hemorrhoidectomy
• Mastectomy
* Dermabrasion
* Appendectomy (open and laparoscopic)
* Bowel resection (open and laparoscopic)
* Colectomy
* Liver resection
* Resections of organs
* Thyriodectomy
* Adhesiolysis
* Hepatobiliary tumors
* Throacotomy
* Cholecystectomy (open and laparoscopic)
* Condyloma
* Breast biopsy
Neurosurgery:
* Percutaneous Disc Decompression
* Discectomy
* Hemostasis in conjunction with meningiomas
Laser 980 nm
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 varicies
· Excision of polyps
Arthroscopy:
* Chondromalacia
* Synovectomy
* Menisectomy
Laser 980 nm
Thoracic Surgery:
* Thoracotomy
* Pulmonary resection
* Hemostasis
* Pericardiectomy
* Adhesiolysis
· Coagulation of blebs and bullae
Pulmonology:
- Endoscopic pulmonary applications
; Tracheal bronchial lesions
*Benign and 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
Laser 980 nm
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 telangiectasis, veinulectasisas 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, venus lakes, Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.
Laser 980 nm
Dermatology/ Aesthetics: Continued
* Dermatological surgery: Chondyloma acuminate, warts, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcoma. Warty leucoplasy and ulcers debridement.
* Seborrheic keratoses
· Mixoid cyst
* Papillary varix
* Acne treatment
· Hair removal of unwanted hair from skin types 1-V
Plastic Surgery:
* Cut, coagulation & vaporization
* Resurfacing
* Blepharoplasty
Vascular Surgery:
· Endoluminal or endovenous laser surgery for saphenous incompetent veins
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091323: Modified Intermedic Diode Laser 980NM System (Multidiode SST 200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091323
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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