510(k) · Cleared
ClearedAcuPulse CO2 Laser System, Delivery Devices and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Oct 19, 2021 as substantially equivalent to K180597 (Lumenis, Ltd., 2018) and 2 other predicates after a 54-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Oct 19, 2021
- Review
- 54 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K936109 (1994). 31 ancestors in all, the oldest K822136 (1982). No later device cites it as a predicate yet.
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations between
- 3 generations backK180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G…Lumenis, Ltd. · 2018
- 2 generations backK201663 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- 1 generation backK202428 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- This deviceK212703 AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 9 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 8 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 7 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 6 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- 5 generations backK082809 Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc. · 2008
- 4 generations backK100415 Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis · 2010 · Recalled
- 3 generations backK180597 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G…Lumenis, Ltd. · 2018
- 2 generations backK201663 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- 1 generation backK202428 AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd. · 2020
- This deviceK212703 AcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −10 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −8 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −7 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −6 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| −5 | K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | Lumenis, Inc. | 2008 | — |
| −4 | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System | Lumenis | 2010 | 1 |
| −3 | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Lumenis, Ltd. | 2018 | — |
| −2 | K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020 | — |
| −1 | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | Lumenis, Ltd. | 2020 | — |
| 0 (this device) | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | Lumenis, Ltd. | 2021 | — |
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 |
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? (3)
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 |
|---|---|---|---|
| * | K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOSummary page 9…Page 1 of 10 Predicate Device: AcuPulse System, member of the AcuPulse Family of CO2 Lasers systems (K180597) and AcuPulse W (K201663 and K202428). Intended Use/ Indications for Use: The Lumenis AcuPulse CO2 Laser System, Delivery Devic… | 2018 |
| * | K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSummary page 9…Predicate Device: AcuPulse System, member of the AcuPulse Family of CO2 Lasers systems (K180597) and AcuPulse W (K201663 and K202428). Intended Use/ Indications for Use: The Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is in… | 2020 |
| * | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSummary page 9…=== Predicate Device: AcuPulse System, member of the AcuPulse Family of CO2 Lasers systems (K180597) and AcuPulse W (K201663 and K202428). Intended Use/ Indications for Use: The Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for… | 2020 |
| † | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System | 2010 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 1 other device also cites its predicate K180597.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated 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 Lumenis modified AcuPulse CO2 Laser System, Delivery…
Read the full statement (1,375 words)
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 debridement
* 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:
- Keratosis, including actinic and seborrheic keratosis, seborrhoea vulgares, seborrheic wart and verruca 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 pyogenic granulomas/granuloma pyogenicum/granuloma
telangiectaticum)
- Tattoos
- Telangiectasia
- Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
- Superficial pigmented lesions
- Adenosebaceous hypertrophy or sebaceous hyperplasia
- Rhinophyma reduction
- Cutaneous papilloma (skin tags)
- Milia
- Debridement of eczematous or infected skin
- Basal and squamous cell carcinoma, including keratoacanthomas, Bowen’s disease (Erythroplasia of Queyrat), and
Bowenoid Papulosis (BP) lesions
- Nevi, including spider, epidermal and protruding
- Neurofibromas
- Laser de-epithelialization
- Tricoepitheliomas
- Xanthelasma palpebrarum
- Syringoma
» Laser ablation, vaporization, and/or excision for complete and partial nail matrixectomy
* Vaporization or coagulation of:
- Benign/malignant vascular/avascular skin lesions
- Moh’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
Podiatry
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated 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
Otolaryngology (ENT)
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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
- Polypectomy 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 Diverticulum/pharyngoesophageal diverticulum (endoscopic laser-assisted esophagodiverticulostomy
(ELAED))
- Stenosis, including subglottic stenosis
- Tonsillectomy (including tonsillar 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 neuroma in the ear
- Superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler’s disease
- Telangiectasia’hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
- Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of
larynx, pharynx and trachea
- Myringotomy/tympanostomy (tympanic membrane fenestration)
- Uvulopalatoplasty (LAUP, laser UPPP)
- Turbinectomy and turbinate reduction/ablation
- 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the following
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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for incision, excision
and vaporization of soft tissue in orthopedic surgery, including the following applications:
* Arthroscopy
- Meniscectomy
- Chondromalacia
- 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
General and Thoracic Surgery
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated 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, diabetic, and other ulcers
- Mastectomy
- Debridement of burns
- 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
- Pilonidal cyst removal and repair
- Abscesses
- Other soft tissue applications
Dental and Oral Surgery
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the incision,
excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- Gingivectomy/removal of hyperplasias
- Gingivoplasty
- Incisional and excisional biopsy
- Treatment of ulcerous lesions, including aphthous ulcers
- Incision of infection when used with antibiotic therapy
- Frenectomy (frenum release)
- Excision and ablation of benign and malignant lesions
- Homeostasis
- 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
- Periodontal gum resection
The Lumenis modified AcuPulse Laser System, Delivery Devices and Accessories when used in conjunction with
FemTouch and FemX, is indicated for the vaporization, incision, excision, ablation and coagulation of body soft tissue in
medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology,
neurosurgery, orthopedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin
resurfacing.
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/K212703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212703: AcuPulse CO2 Laser System, Delivery Devices and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212703
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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