510(k) · Cleared
ClearedSpectra-SP CO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Max Engineering, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 15, 2005 as substantially equivalent to K030147 (Lumenis, Ltd., 2003) and 6 other predicates after a 71-day review. Its family tree reaches back 6 generations to 1994. 13 later devices descend from it.
- Decided
- Apr 15, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K936109 (1994). 26 ancestors in all, the oldest K822136 (1982). 13 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 2 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 1 generation backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- This deviceK050254 Spectra-SP CO2 Laser SystemMax Engineering, Ltd. · 2005
- Descendant · cites it directly · 12 of its ownK091320 Spectra SP II, Spectra Denta IILutronic Corporation · 2009
- Descendant · 2 generations on · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK123494 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 3 of its ownK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- Descendant · 3 generations on · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K091320Spectra SP II, Spectra Denta IILutronic Corporation · 2009 · cites it directly12descendants
- K132661LightscalpelLightscalpel, LLC · 2014 · 2 generations on3descendants
- K123494SOLEAConvergent Dental, Inc. · 2013 · 2 generations on3descendants
- K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation · 2011 · 2 generations on3descendants
- K141658Light ScalpelLightscalpel, LLC · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −5 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −3 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −2 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −1 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| 0 (this device) | K050254 | Spectra-SP CO2 Laser System | Max Engineering, Ltd. | 2005 | — |
| +1 | K091320 | Spectra SP II, Spectra Denta II | Lutronic Corporation | 2009 | — |
| +2 | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K123494 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
| +2 | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems | Lutronic Corporation | 2011 | — |
| +3 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersSummary page 1…icate Devices The Spectra-SP Laser System is substantially equivalent to a combination of the Lumenis Family of UltraPulse SurgiTouch C02 Laser Systems (K030147), the Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (K022060), the Lum… | 2003 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…amily of UltraPulse SurgiTouch C02 Laser Systems (K030147), the Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (K022060), the Lumenis Compact 20C, 30C and 40C C02 Lasers (K935563 and K963229), the ESC Medical Systems Luxar LX-20 C02 Surgical… | 2002 |
| * | K935563 | Sharplan Surgical CO2 Lasers and AccessoriesSummary page 1…Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (K022060), the Lumenis Compact 20C, 30C and 40C C02 Lasers (K935563 and K963229), the ESC Medical Systems Luxar LX-20 C02 Surgical Laser System Family (K991628 and K960475), and the MedArt… | 1994 |
| * | K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersSummary page 1…UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (K022060), the Lumenis Compact 20C, 30C and 40C C02 Lasers (K935563 and K963229), the ESC Medical Systems Luxar LX-20 C02 Surgical Laser System Family (K991628 and K960475), and the MedArt Uni-Laser 45… | 1996 |
| * | K991628 | Modified LX-20 CO2 Laser System Family, LX-20SASummary page 1…s (K022060), the Lumenis Compact 20C, 30C and 40C C02 Lasers (K935563 and K963229), the ESC Medical Systems Luxar LX-20 C02 Surgical Laser System Family (K991628 and K960475), and the MedArt Uni-Laser 450[' C02 Laser System & Accessories (K991297). 4. Device Description… | 1999 |
| * | K960475 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 1…the Lumenis Compact 20C, 30C and 40C C02 Lasers (K935563 and K963229), the ESC Medical Systems Luxar LX-20 C02 Surgical Laser System Family (K991628 and K960475), and the MedArt Uni-Laser 450[' C02 Laser System & Accessories (K991297). 4. Device Description The Spectr… | 1996 |
| * | K991297 | Uni-Laser 450P CO2 Laser System & AccessoriesSummary page 1…he ESC Medical Systems Luxar LX-20 C02 Surgical Laser System Family (K991628 and K960475), and the MedArt Uni-Laser 450[' C02 Laser System & Accessories (K991297). 4. Device Description The Spectra-SP Laser System consists of a self-contained console, an articulated ar… | 1999 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091320 | Spectra SP II, Spectra Denta II | 2009 | 12 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K091320 (Lutronic Corporation, 2009) has gone furthest, with 12 descendants of its own.
- 14 other devices also cite its predicate K030147.
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 Spectra-SP Laser System is 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, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery. Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue…
Read the full statement (354 words)
The Spectra-SP Laser System is 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, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open 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 elastosis, 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 naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology, Plastic Surgery & General 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, homeostatis, 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 of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, 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 as stated in the FDA summary.
https://510kreport.com/device/K050254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050254: Spectra-SP CO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050254
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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