510(k) Report

510(k) · Cleared

Cleared

Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)

K091323510(k) SpecialCleared Jun 4, 200930-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year cleared 2005: 4 other ancestors2004: 6 other ancestors2003: 12 other ancestors2002: 17 other ancestors2001: 12 other ancestors2000: 13 other ancestors2006: 1 other ancestor1998: 9 other ancestors1997: 18 other ancestors1995: 13 other ancestors1999: 6 other ancestors1996: 14 other ancestors1990: 2 other ancestors1993: 6 other ancestors1994: 9 other ancestors1989: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1992: 3 other ancestors1991: 3 other ancestorsK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006×2: 2 generations cleared close together, K071295 (2007), K072106 (2007) K083682 · 180W Cerelas D 980NM Diode Laser, Model D180 · Biolitec, Inc. · 20091980198519901995200020052010
Other ancestors, by generation 2 generations back: 14 other ancestors3 generations back: 15 other ancestors4 generations back: 31 other ancestors5 generations back: 33 other ancestors6 generations back: 23 other ancestors7 generations back: 30 other ancestors8 generations back: 3 other ancestors9 generations back: 2 other ancestors K083682 · 180W Cerelas D 980NM Diode Laser, Model D180 · Biolitec, Inc. · 2009K072106 · 150W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K071295 · 100W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50
  1. Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 13 generations between
  3. 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  4. 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  5. 1 generation backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  6. This deviceK091323 Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA · 2009
Show all 17 generations
  1. Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. 1 generation backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  18. 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

GenerationNumberDeviceApplicantDecidedRecalls
−17K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−16K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−15K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−14K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−13K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−12K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−11K000944Thermage Thermacool SystemThermage, Inc.2000—
−10K013034Modification to: Thermacool IiaThermage, Inc.2001—
−9K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−8K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−7K030142Thermacool TC SystemThermage, Inc.2003—
−6K031671Polaris WRSyneron Medical, Ltd.2003—
−5K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−2K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−1K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
0 (this device)K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198910
199020
199130
199230
199360
199490
1995130
1996140
1997180
199890
199960
2000130
2001120
2002170
2003120
200460
200540
200610
FIG. 1 — Lineage of K091323, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K053540Intermedic 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…
Intermedic Arfran, SA2006—
*K083682180W Cerelas D 980NM Diode Laser, Model D180
Summary 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…
Biolitec, Inc.2009—

Also cleared against K053540: 7 other devices →

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 devices

GEX 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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