# K033072: Lucentlite, Model Imd 010

- Pathway: 510(k) (Traditional)
- Applicant: Industrial & Medical Design, Inc.
- Decided: Apr 1, 2004 after 185 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: 7 generations back to K910422 (1992). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K003202: Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II, Altus Medical (2001) Summary page 1.
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems, Cooltouch Corp. (2002) Summary page 1.
- K022466: Profile 1320 Laser System, Sciton, Inc (2002) Summary page 1.

## Indications for use
The LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology: 1064 nm: - To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles. - For the removal of unwanted hair. - For coagulation and hemostasis of vascular lesions. - For Incision/excision of soft body tissues in dermatology. - For soft tissue general surgery applications: skin incision; tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation. * Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after treatment regimen. 1320 nm: - For the treatment of periorbital and perioral wrinkles.

Source page: https://510kreport.com/device/K033072
Methodology: https://510kreport.com/methodology