510(k) · Cleared
ClearedLightscalpel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightscalpel, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jan 2, 2014 as substantially equivalent to K123037 (Lightscalpel, LLC, 2012) and 6 other predicates after a 129-day review. Its family tree reaches back 8 generations to 1994. 3 later devices descend from it.
- Decided
- Jan 2, 2014
- Review
- 129 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K936109 (1994). 66 ancestors in all, the oldest K822136 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 3 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- 2 generations backK050254 Spectra-SP CO2 Laser SystemMax Engineering, Ltd. · 2005
- 1 generation backK091320 Spectra SP II, Spectra Denta IILutronic Corporation · 2009
- This deviceK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · cites it directly · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK213669 Lightscalpel LS-4020Lightscalpel, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK173827 LightScalpelLightscalpel, LLC · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −3 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| −2 | K050254 | Spectra-SP CO2 Laser System | Max Engineering, Ltd. | 2005 | — |
| −1 | K091320 | Spectra SP II, Spectra Denta II | Lutronic Corporation | 2009 | — |
| 0 (this device) | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +1 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K213669 | Lightscalpel LS-4020 | Lightscalpel, Inc. | 2023 | — |
| +2 | K173827 | LightScalpel | Lightscalpel, LLC | 2018 | — |
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 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K123037 | LightscalpelSummary page 1…Classification: Class 11 Product Code: GEX 4. Predicate Device(s) The LightScalpel LS-i0 / LS-1 005 002 Laser System was previously cleared per K1 23037. Additional Indications for Use are equivalent to the following predicates: 4.1 K081612, Aesculight / K1 21471, Li… | 2012 |
| * | K081612 | Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical LasersSummary page 1…S-i0 / LS-1 005 002 Laser System was previously cleared per K1 23037. Additional Indications for Use are equivalent to the following predicates: 4.1 K081612, Aesculight / K1 21471, LightScalpel Laser Accessories 4.2 K960475, Luxar LX2O 002 Laser System 4.3 K091320, Lu… | 2008 |
| * | K121471 | Lightscalpel Family of Handpiece Tips for CO2 Surgical LasersSummary page 1…ser System was previously cleared per K1 23037. Additional Indications for Use are equivalent to the following predicates: 4.1 K081612, Aesculight / K1 21471, LightScalpel Laser Accessories 4.2 K960475, Luxar LX2O 002 Laser System 4.3 K091320, Lutronic Spectra DENTA 11… | 2012 |
| * | K960475 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 1…Additional Indications for Use are equivalent to the following predicates: 4.1 K081612, Aesculight / K1 21471, LightScalpel Laser Accessories 4.2 K960475, Luxar LX2O 002 Laser System 4.3 K091320, Lutronic Spectra DENTA 11C02 Laser System 4.4 K100416, Lumenis AcuPul… | 1996 |
| * | K091320 | Spectra SP II, Spectra Denta IISummary page 1…t to the following predicates: 4.1 K081612, Aesculight / K1 21471, LightScalpel Laser Accessories 4.2 K960475, Luxar LX2O 002 Laser System 4.3 K091320, Lutronic Spectra DENTA 11C02 Laser System 4.4 K100416, Lumenis AcuPulse 002 Laser System 4.5 K971 743, Sharpla… | 2009 |
| * | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System Our reading of the summary gave K100416, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lumenis AcuPulse CO2 Laser System”. | 2010 |
| * | K971743 | Sharplan CO2 Surgical Laser SystemSummary page 1…K960475, Luxar LX2O 002 Laser System 4.3 K091320, Lutronic Spectra DENTA 11C02 Laser System 4.4 K100416, Lumenis AcuPulse 002 Laser System 4.5 K971 743, Sharplan 15F C02 Laser System 001 Sum3 VOL 006-001 Page 1 of 5 ===… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141658 | Light Scalpel | 2014 | 2 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 66 ancestors has a recall of any class.
- Of its descendants, K141658 (Lightscalpel, LLC, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K123037.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 LightScalpel LS-1005 C02 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, podiatry, and urology. Dental Procedures: Gingivectomy - Removal of hyperplasias; Gingivopiasty; Papillectomy; Vestibuloplasty; Epulis…
Read the full statement (165 words)
The LightScalpel LS-1005 C02 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, podiatry, and urology.
Dental Procedures:
Gingivectomy - Removal of hyperplasias; Gingivopiasty; Papillectomy; Vestibuloplasty; Epulis; Sulcular Debridement; Removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); Extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; A heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium).
Oral Surgery Procedures:
Frenum Release/Frenectomy; Drainage (abscess); Flap Surgery; Biopsy (incisional & excisional); Aphthous Ulcers (incision & excision); Incision of Infection when used with antibiotic therapy; Excision & Ablation of lesions, benign & malignant lesions, oral cavity tumors, and hemangiomas; Salivary Gland Pathologies; Preprosthetic Gum Preparation, Leukoplakia; Partial Glossectomy; Periodontial Gum Resection; H-omeostasis; Operculectomy; Crown Lengthening (soft tissue).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132661: Lightscalpel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132661
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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