510(k) · Cleared
ClearedLightscalpel Family of Handpiece Tips for CO2 Surgical Lasers
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 Jul 10, 2012 as substantially equivalent to K081612 (Aesculight, LLC, 2008) after a 53-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 10, 2012
- Review
- 53 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953074 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 2 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- 1 generation backK081612 Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2…Aesculight, LLC · 2008
- This deviceK121471 Lightscalpel Family of Handpiece Tips for CO2 Surgical LasersLightscalpel, LLC · 2012
- Descendant · cites it directly · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK213669 Lightscalpel LS-4020Lightscalpel, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK173827 LightScalpelLightscalpel, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K132661LightscalpelLightscalpel, LLC · 2014 · cites it directly3descendants
- K141658Light ScalpelLightscalpel, LLC · 2014 · 2 generations on2descendants
- K213669Lightscalpel LS-4020Lightscalpel, Inc. · 2023 · 3 generations on0descendants
- K173827LightScalpelLightscalpel, LLC · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −2 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| −1 | K081612 | Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical… | Aesculight, LLC | 2008 | — |
| 0 (this device) | K121471 | Lightscalpel Family of Handpiece Tips for CO2 Surgical Lasers | Lightscalpel, LLC | 2012 | — |
| +1 | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
| +3 | K213669 | Lightscalpel LS-4020 | Lightscalpel, Inc. | 2023 | — |
| +3 | K173827 | LightScalpel | Lightscalpel, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K081612 | Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical LasersSummary page 1…GEX . Panel: General and plastic surgery devices, Legally marketed predicate device: Aesculight family of fibers, handpieces, and tips for CO2 surgical lasers. (K081612) Device description: These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132661 | Lightscalpel | 2014 | 3 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132661 (Lightscalpel, LLC, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K081612.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Intended use isto communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use: Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; l&D Bartholin's and nubothian cysts. Dermatology -…
Read the full statement (209 words)
Intended use isto communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:
Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; l&D Bartholin's and nubothian cysts.
Dermatology - port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.
Dentistry/Oral Surgery - gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery - hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; dlebridement of dleciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.
Laparoscopic surgery - vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.
Otorhinolaryngolagy - lymphangiomna removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.
Podiatry - plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment
Orthopedic - menisectomy; chondramalacia ablation; partial synovectomy, lateral release, PMMA removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121471 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121471: Lightscalpel Family of Handpiece Tips for CO2 Surgical Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121471
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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