# K050254: Spectra-SP CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Max Engineering, Ltd.
- Decided: Apr 15, 2005 after 71 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: 6 generations back to K936109 (1994). 26 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.
- K935563: Sharplan Surgical CO2 Lasers and Accessories, Sharplan Lasers, Inc. (1994) Summary page 1.
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers, Sharplan Lasers, Inc. (1996) Summary page 1.
- K991628: Modified LX-20 CO2 Laser System Family, LX-20SA, Esc Medical Systems, Inc. (1999) Summary page 1.
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.
- K991297: Uni-Laser 450P CO2 Laser System & Accessories, Medart Corp. (1999) Summary page 1.

## Most influential descendants
- K091320: Spectra SP II, Spectra Denta II (2009), 12 descendants of its own
- K132661: Lightscalpel (2014), 3 descendants of its own
- K123494: SOLEA (2013), 3 descendants of its own
- K100610: Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems (2011), 3 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own

## Indications for use
The Spectra-SP Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery. Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: -Laser skin resurfacing -Treatment of wrinkles, rhytids and furrows -Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement. Dermatology, Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications. Soft Tissue Dental The specific soft tissue dental indications include: Periodontic procedures such as gingivectomy-removal of hyperplasias, gingivoplasty, and incision and excision; Oral surgery such as frenectomy, incisional and excisional biopsy, incision and excision of aphous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, homeostatis, operculectomy, and crown lengthening. Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy. Otorhinolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares. Gynecology Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia. Neurosurgery, Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.

Source page: https://510kreport.com/device/K050254
Methodology: https://510kreport.com/methodology