# K073158: Sculpture 2.94 ER:Yag System

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Conbio, Inc.
- Decided: Aug 27, 2008 after 293 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: 14 generations back to K943450 (1995). 374 ancestors in all.
No later device cites it as a predicate yet.
0 of 375 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970934: CB Erbium/2.94(TM) ER:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 1.
- K041710: Versawave Dental ER:Yag Laser System, Hoya Conbio (2004) Summary page 1.
- K933057: Multilite Erbium:Yag Surgical Laser System, Continuum Electro-Optics, Inc. (1994) Summary page 2.
- K990243: Fotona Fidelis ER:Yag Laser System & Accessories, Fotona D.D. (1999) Summary page 1.
- K070138: Cutera ER:Yag Laser Handpiece, Cutera, Inc. (2007) Summary page 1.
- K070392: Mosaic Laser System, Lutronic Corporation (2007) Summary page 3.
- K071768: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 3.
- (no number) SmoothPeel Laser Peel: named in the summary without a submission number

## Indications for use
The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.

Source page: https://510kreport.com/device/K073158
Methodology: https://510kreport.com/methodology