# K132661: Lightscalpel

- Pathway: 510(k) (Traditional)
- Applicant: Lightscalpel, LLC
- Decided: Jan 2, 2014 after 129 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: 8 generations back to K936109 (1994). 66 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123037: Lightscalpel, Lightscalpel, LLC (2012) Summary page 1.
- K081612: Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical Lasers, Aesculight, LLC (2008) Summary page 1.
- K121471: Lightscalpel Family of Handpiece Tips for CO2 Surgical Lasers, Lightscalpel, LLC (2012) Summary page 1.
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.
- K091320: Spectra SP II, Spectra Denta II, Lutronic Corporation (2009) Summary page 1.
- K100415: Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System, Lumenis (2010). 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”. Summary page 4.
- K971743: Sharplan CO2 Surgical Laser System, Sharplan Lasers, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
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).

Source page: https://510kreport.com/device/K132661
Methodology: https://510kreport.com/methodology