# K081612: Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Aesculight, LLC
- Decided: Jun 25, 2008 after 16 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953074 (1995). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.

## Most influential descendants
- K121471: Lightscalpel Family of Handpiece Tips for CO2 Surgical Lasers (2012), 4 descendants of its own
- K132661: Lightscalpel (2014), 3 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own
- K213669: Lightscalpel LS-4020 (2023), 0 descendants of its own
- K173827: LightScalpel (2018), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K081612
Methodology: https://510kreport.com/methodology