510(k) · Cleared
Recalled · Class II · 2016Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis · GEX Powered Laser Surgical Instrument
Cleared on Apr 21, 2010 as substantially equivalent to K082809 (Lumenis, Inc., 2008) after a 64-day review. Its family tree reaches back 7 generations to 1994. 10 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K936109 (1994). 27 ancestors in all, the oldest K822136 (1982). 10 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 5 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 4 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 3 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 2 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- 1 generation backK082809 Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc. · 2008
- This deviceK100415 Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis · 2010
- Descendant · cites it directly · 3 of its ownK180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G…Lumenis, Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK201663 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
- Descendant · 3 generations on · 1 of its ownK202428 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd. · 2018 · cites it directly3descendants
- K132661LightscalpelLightscalpel, LLC · 2014 · cites it directly3descendants
- K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020 · 2 generations on2descendants
- K141658Light ScalpelLightscalpel, LLC · 2014 · cites it directly2descendants
- K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −6 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −4 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −3 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −2 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| −1 | K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | Lumenis, Inc. | 2008 | — |
| 0 (this device) | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System | Lumenis | 2010 | — |
| +1 | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Lumenis, Ltd. | 2018 | — |
| +1 | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020 | — |
| +1 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
| +3 | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082809 | Acupulse 30 and 40 Carbon Dioxide Laser SystemSummary page 1….4810 3. Predicate Devices The modified C02 Laser WaveGuide is substantially equivalent to the following device: 510(k) No. Manufacturer Device K082809 Lumenis Ltd. AcuPulse 30/40 ST C02 Laser Systems 4. Indications for Use The intended us… | 2008 |
What descends from it? (10)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2016 | Class II | Z-0301-2017 | Software Manufacturing/Software Deployment | The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K180597 (Lumenis, Ltd., 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K082809.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 intended use of the AcuPulse 30/40 ST C02 Laser Systems and AcuPulse 4OWG C02 Laser series is for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry. The intended use of the AcuPulse series is for the performance of specific…
Read the full statement (1,251 words)
The intended use of the AcuPulse 30/40 ST C02 Laser Systems and AcuPulse 4OWG C02 Laser series is for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
The intended use of the AcuPulse series is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows:
Dermatology
The AcuPulse laser is indicated for use in dermatology and plastic surgery for the following applications:
* Ablation, vaporization, excision, incision and coagulation of soft tissue in the performance of:
- Laser skin resurfacing
- Laser dermabrasion
- Laser burn debridemnent
* Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
- Wrinkles, rhytids and furrows (including fine lines and texture irregularities).
* Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheci wart and verruUT seborrheica:-
- Vermillionectomy of the lip
- Cutaneous horns
- Solar/actinic elastosis
- Cheilitis, including actinic cheilitis
- Lentigines, including lentigo maligna or Hutchinson's malignant freckle
- Uneven pigmentation/dyschromia
- Acne scars
- Surgical scars
- Keloids including acne keloidalis nuchae
- Hemangiomas (including Buccal, port wine and pygnci* pyogenicum/granuloma telangiectaticum)
- Tatoos
- Telangiectasia
- Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
- Superficial pigmented lesions
- Adenosebaceous hypertrophy or sebaceous hyperplasia
- Rhinophyma reduction
- Cutaneous papillomna (skin tags)
- Milia
- Debridement of eczematous or infected skin
- Bramnous and sqlarous cell carcinoma,including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
- Nevi, including spider, epidermal and protruding
- Neurofibromas
- Laser de-epitheliazation
- Tricoepitheliomas
- Xanthelasma palpebrarum
- Syringomna
* Laser ablation, vaporization, and/or excision for complete and partial nail matrixecomy
* Vaporization/coagulation of:
- Benign/malignant vascular/avascular skin lesions
- Mob's surgery
- Lipectomy
- Verrucae and seborrhoecae vulgares, including paronychial, periungal and subungual warts
* Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty
* Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
PodiatrV
The AcuPulse laser is indicated for use in podiatry for the following applications:
* Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Fungal nail treatment
- Porokeratoma ablation
- Ingrown nail treatment
- Neuromas/fibromas, including Morton's neuroma
- Debridement of ulcers
- Other soft tissue lesions
* Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy
Otolarvngolosrv (ENT)
The AcuPulse laser is indicated for laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of:.
* Choanal atresia
* Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue
* Nasal obstruction
* Adult and juvenile papillomatosis polyps
* Polypectomny of nose and nasal passages
* Lymphangioma removal
* Removal of vocal cord/fold nodules, polyps and cysts
* Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords.
* Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue
* Zenker' s Diver-ticulum/pharyngoesophageaI diverticulumn (endoscopic laser-assisted esophagodiverticulostomy (ELAED))
* Stenosis, including subglottic stenosis
* Tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
* Pulmonary bronchial and tracheal lesion removal
* Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
* Benign and malignant lesions and fibromas (nose and nasal passages)
* Benign and malignant tumors and fibromas (oral)
* Stapedotomy/Stapedectomy
* Acoustic neuiomna in the ear
* Superficial lesions of the ear, including chondrodermatitis nondularis chroniUT helices/Winkler's disease
* Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
* Cordectomny, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
* Myringotomy/tymnpanostomy (tympanic membrane fenestration)
* Uvulopalatoplasty (LAUP, laser UPPP)
* Turbinectomy and turbinate reduction/ablationKt{ea
* Septal spur ablation/reduction and septoplasty
* Partial glossectomy
* Tumor resection of oral, subfacial and neck tissues
* Rhinophyma
* Verrucae vulgares (warts)
* Gingivoplasty/gingivectomy
Gynecology and GYN Laparoscopy Indications
The AcuPulse laser is indicated for use in gynecology for the followig applications:
* Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
- Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP lesions)
- Leukoplakia (vulvar dystrophies)
- Incision and drainage (I&D) of Bartholin’s and nabothian cysts
- Herpes vaporization
- Urethral caruncle vaporization
- Cervical dysplasia
- Benign and malignant tumors
- Hemangiomas
* Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of:
- Endometrial lesions, including ablation of endometriosis
- Excision/lysis adhesions
- Salpingostomy
- Oophorectomy
- Fimbrioplasty
- Metroplasty
- Microsurgery (tubal)
- Uterine myomas and fibroids
- Ovarian fibromas and follicle cysts
- Uterosacral ligament ablation
- Hysterectomy
Neurosurgery Indications
The AcuPulse laser is indicated for laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:
* Cranial
- Posterior fossa tumors
- Peripheral neurectomy
- Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors
- Arteriovenous malformation
- Pituitary gland tumors (transphenoidal approach)
* Spinal cord
- Incision/excision and vaporization of benign and malignant tumors and cysts
- Intra and extradural lesions
- Laminectomy/laminotomy/microdiscectomy
Orthopedic Indication
The AcuPulse Laser is indication for incision, excision and vaporization of soft tissue in orthopedic surgery, including the following applications:
* Arthroscopy
- Meniscectorny
- Chondromnalacia
- Chondroplasty
- Ligament release (lateral and other)
- Excision of plica
- Partial synovectomy
* General
- Debridement of traumatic wounds
- Debridement of decubitus and diabetic ulcers
- Microsurgery
- Artificial joint revision
- PMMA removal
Gcneral and Thoracic Surgery
The AcuPulse Laser is indication for the incision, excision and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures. Applications include:
* Debridement of decubitus ulcers stasis, diabeti6, and other ulcers
* Mastectomy
* Debridement of bums
* Rectal and anal hemorrhoidectomy
* Breast biopsy
* Reduction mammoplasty
* Cytoreduction for metastatic disease
* Laparotomy and laparoscopic applications
* Mediastinal and thoracic lesions and abnormalities
* Skin tag vaporization
* Atheroma
* Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
* Pilondial cyst removal and repair
* Abscesses
* Other soft tissue applications
Dental and Oral Surg~ery
The AcuPulse Laser is indication for the incision, excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
* Gingivectomy/removal of hyperplasia~s
* Gingivoplasty
* lncisional and excisional biopsy
* Treatment of ulcerous lesions, including aphthous ulcers
* Incision of infection when used with antibiotic therapy
* Frenectomy (frenumn release)
* Excision and ablation of benign and malignant lesions
* H-omneostasis
* Operculectomy
* Crown lengthening
* Removal of soft tissue, cysts and tumors
* Oral cavity tumors and hemangiomas
* Abscesses
* Extraction site hemostasis
* Salivary gland pathologies
* Preprosthetic gum preparation
* Leukoplakia
* Partial glossectomy
* Periodental gum resection
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/K100415 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100415: Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100415
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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