510(k) · Cleared
ClearedUni-Laser 450P CO2 Laser System & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medart Corp. · GEX Powered Laser Surgical Instrument
Cleared on Jul 12, 1999 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 481 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
481 later devices descend from it, 6 citing it directly.
- This deviceK991297 Uni-Laser 450P CO2 Laser System & AccessoriesMedart Corp. · 1999
- Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- Descendant · 2 generations on · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- Descendant · 2 generations on · 318 of its ownK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003
- Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- Descendant · 2 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
Showing 5 of 481 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 481 · See all- K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
- K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 2 generations on323descendants
- K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 2 generations on318descendants
- K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants
- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 2 generations on284descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991297 | Uni-Laser 450P CO2 Laser System & Accessories | Medart Corp. | 1999 | — |
| +1 | 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 | — |
| +2 | K031795 | Reliant Laser System | Reliant Technologies, Inc. | 2003 | — |
| +2 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| +2 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 22 | 0 |
| 2009 | 11 | 0 |
| 2010 | 16 | 0 |
| 2011 | 17 | 0 |
| 2012 | 12 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 17 | 0 |
| 2016 | 20 | 0 |
| 2017 | 15 | 0 |
| 2018 | 24 | 0 |
| 2019 | 11 | 0 |
| 2020 | 30 | 0 |
| 2021 | 21 | 0 |
| 2022 | 40 | 0 |
| 2023 | 29 | 0 |
| 2024 | 50 | 0 |
| 2025 | 53 | 0 |
| 2026 | 29 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (481)
See all 4816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories | 2002 | 376 |
| K021508 | Opusduo EC Dental Laser System | 2002 | 240 |
| K050254 | Spectra-SP CO2 Laser System | 2005 | 13 |
| K091320 | Spectra SP II, Spectra Denta II | 2009 | 12 |
| K083123 | Medart Model 610 CO2 Laser System & Accessories | 2009 | 0 |
| K020408 | System 2000 Controller, System 5000 Controller, Footswitch, Power Cord, and Visage Wandsff | 2002 | 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?
- Of its descendants, K022060 (Lumenis, Inc., 2002) has gone furthest, with 376 descendants of its own.
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 Uni-laser 450P CO; Laser System & Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, ncurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery. Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and…
Read the full statement (357 words)
The Uni-laser 450P CO; Laser System & Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, ncurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open and endoscopic general surgery.
Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
Laser skin resurfacing
Treatment of wrinkles, rhytids and furrows
Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic clastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas) tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal nacvi, xanthelasma palpebrarum, syringoma, and verrucac and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surger neral Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Soft Tissue Dental The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision;
Oral Surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostasis, operculectomy, and crown lengthening.
Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy.
Otorhinolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis . rhinophyma and verrucae vulgares.
Gynecology Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia.
Neurosurgery Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991297: Uni-Laser 450P CO2 Laser System & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991297
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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