510(k) · Cleared
ClearedSpectra SP II, Spectra Denta II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · GEX Powered Laser Surgical Instrument
Cleared on Aug 19, 2009 as substantially equivalent to K050254 (Max Engineering, Ltd., 2005) and 6 other predicates after a 106-day review. Its family tree reaches back 7 generations to 1994. 12 later devices descend from it.
- Decided
- Aug 19, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K936109 (1994). 57 ancestors in all, the oldest K822136 (1982). 12 later devices descend from it, 3 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 backK050254 Spectra-SP CO2 Laser SystemMax Engineering, Ltd. · 2005
- This deviceK091320 Spectra SP II, Spectra Denta IILutronic Corporation · 2009
- Descendant · cites it directly · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · cites it directly · 3 of its ownK123494 SOLEAConvergent Dental, Inc. · 2013 · Recalled
- Descendant · cites it directly · 3 of its ownK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- Descendant · 2 generations on · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK130420 SOLEAConvergent Dental, Inc. · 2013 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132661LightscalpelLightscalpel, LLC · 2014 · cites it directly3descendants
- K123494SOLEAConvergent Dental, Inc. · 2013 · cites it directly3descendants
- K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation · 2011 · cites it directly3descendants
- K141658Light ScalpelLightscalpel, LLC · 2014 · 2 generations on2descendants
- K130420SOLEAConvergent Dental, Inc. · 2013 · 2 generations on2descendants
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 | K050254 | Spectra-SP CO2 Laser System | Max Engineering, Ltd. | 2005 | — |
| 0 (this device) | K091320 | Spectra SP II, Spectra Denta II | Lutronic Corporation | 2009 | — |
| +1 | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +1 | K123494 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
| +1 | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems | Lutronic Corporation | 2011 | — |
| +2 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K130420 | SOLEA | Convergent Dental, Inc. | 2013 | 1 |
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 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050254 | Spectra-SP CO2 Laser SystemSummary page 1…es The Spectra DENTA II and Spectra SP II Laser Systems are substantially equivalent to a combination of the Lutronic Corporation Spectra SP Laser System (K050254), the Lumenis Family of UltraPulse SurgiTouch C02 Laser Systems (K030147), the Lumenis Compact 30C C02 Lasers (K935… | 2005 |
| * | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersSummary page 1…y equivalent to a combination of the Lutronic Corporation Spectra SP Laser System (K050254), the Lumenis Family of UltraPulse SurgiTouch C02 Laser Systems (K030147), the Lumenis Compact 30C C02 Lasers (K935563 and K963229), the MedArt Uni-Laser 450P C02 Laser System & Accessorie… | 2003 |
| * | K935563 | Sharplan Surgical CO2 Lasers and AccessoriesSummary page 1…Corporation Spectra SP Laser System (K050254), the Lumenis Family of UltraPulse SurgiTouch C02 Laser Systems (K030147), the Lumenis Compact 30C C02 Lasers (K935563 and K963229), the MedArt Uni-Laser 450P C02 Laser System & Accessories (K991297), the OpusDent Ltd. Opus Duo EC (K021508)… | 1994 |
| * | K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersSummary page 1…Spectra SP Laser System (K050254), the Lumenis Family of UltraPulse SurgiTouch C02 Laser Systems (K030147), the Lumenis Compact 30C C02 Lasers (K935563 and K963229), the MedArt Uni-Laser 450P C02 Laser System & Accessories (K991297), the OpusDent Ltd. Opus Duo EC (K021508) and t… | 1996 |
| * | K991297 | Uni-Laser 450P CO2 Laser System & AccessoriesSummary page 1…SurgiTouch C02 Laser Systems (K030147), the Lumenis Compact 30C C02 Lasers (K935563 and K963229), the MedArt Uni-Laser 450P C02 Laser System & Accessories (K991297), the OpusDent Ltd. Opus Duo EC (K021508) and the Cynosure Smart US 20 D / UltraSpeed, and Smart Clinic Laser (K081181).… | 1999 |
| * | K021508 | Opusduo EC Dental Laser SystemSummary page 1…he Lumenis Compact 30C C02 Lasers (K935563 and K963229), the MedArt Uni-Laser 450P C02 Laser System & Accessories (K991297), the OpusDent Ltd. Opus Duo EC (K021508) and the Cynosure Smart US 20 D / UltraSpeed, and Smart Clinic Laser (K081181). 4. Device Description The Spe… | 2002 |
| * | K081181 | Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical LaserSummary page 1…450P C02 Laser System & Accessories (K991297), the OpusDent Ltd. Opus Duo EC (K021508) and the Cynosure Smart US 20 D / UltraSpeed, and Smart Clinic Laser (K081181). 4. Device Description The Spectra DENTA II and Spectra SP II Laser Systems are identical C02 laser systems… | 2008 |
What descends from it? (12)
See all 123 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)
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 15 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- None of the 57 ancestors has a recall.
- Of its descendants, K132661 (Lightscalpel, LLC, 2014) has gone furthest, with 3 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. 2009, 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 Spectra DENTA II Laser System is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and…
Read the full statement (442 words)
The Spectra DENTA II Laser System is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
The Spectra SP II 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.
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/K091320 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091320: Spectra SP II, Spectra Denta II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091320
Report an extraction error
Are you the manufacturer?
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