510(k) · Cleared
ClearedAesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculight, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jun 25, 2008 as substantially equivalent to K960475 (Luxar Corp., 1996) after a 16-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 25, 2008
- Review
- 16 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953074 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 1 generation backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- This deviceK081612 Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2…Aesculight, LLC · 2008
- Descendant · cites it directly · 4 of its ownK121471 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 5 of 5 · See all- K121471Lightscalpel Family of Handpiece Tips for CO2 Surgical LasersLightscalpel, LLC · 2012 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −1 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| 0 (this device) | K081612 | Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical… | Aesculight, LLC | 2008 | — |
| +1 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K960475 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 1…Dental Laser, 21 CFR 878.4810, product code NVK Legally marketed predicate device: Modified LX-20 Laser System fibers, handpieces, and tips, as described in 510(k) no. K960475 Product description This is a family of detachable devices that comprise the distal portion of a beam delivery system to be used… | 1996 |
What descends from it? (5)
2 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 13 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121471 (Lightscalpel, LLC, 2012) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K960475.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Representative examples are listed below. Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts. Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal…
Read the full statement (168 words)
Representative examples are listed below.
Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.
Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis
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; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction 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
Otorhinolaryngoloy--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps
Podiatry--plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment
Orthopedic--menisectomy, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081612: Aesculight Family of Flexible Fibers, Handpieces and 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/K081612
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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