# K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Mar 9, 1998 after 77 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: 3 generations back to K936109 (1994). 9 ancestors in all.
653 later devices descend from it; 3 cite it directly.
0 of 663 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 1.
- K912029: Ultrapulse (TM) Carbon Dioxide Surgical Laser, Coherent Medical Group (1991) Summary page 1.
- K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995) Summary page 1.

## Most influential descendants
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own
- K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and  Delivery (1999), 350 descendants of its own
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own
- K031795: Reliant Laser System (2003), 318 descendants of its own

## Indications for use
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are 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 and endoscopic general surgery. Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), and open and endoscopic general surgery as follows: 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 - Laser derm-abrasion - Laser burn debridement. Dermatology & Plastic Surgery - Continued Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids and furrows. Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO2 surgical laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of: - actinic keratosis - solar/actinic elastosis - actinic cheilitis - lentigines - uneven pigmentation/dyschromia - acne scars - surgical scars - keloids - hemangiomas (including buccal hemangiomas) - tattoos - telangiectasia - squamous cell carcinoma - epidermal nevi - xanthelasma palpebrarum - syringoma - verrucae vulgares (warts). Dermatology, Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty. Laser incision and/or excision of soft tissue in plastic and general surgery for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of: - verrucae vulgares (warts) Laser ablation, vaporization, and/or excision in podiatry for 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 - adult and juvenile papillomatosis polyps - rhinophyma - verrucae vulgares (warts) 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) - vulvar and vaginal intraepithelial neoplasia Neurosurgery Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: - basal tumor-meningioma - posterior fossa tumors - peripheral neurectomy - lipomas/large tumors

Source page: https://510kreport.com/device/K974789
Methodology: https://510kreport.com/methodology