# K082033: Nannolight Intense Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Global USA Distribution, LLC
- Decided: Jul 31, 2008 after 14 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910422 (1992). 64 ancestors in all.
159 later devices descend from it; 1 cites it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- K090195: Palomar LUX1540 Handpiece (2009), 158 descendants of its own
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), 156 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Recalls of this device
- Apr 12, 2008 · Not classified · Z-1444-2009: Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.

## Indications for use
The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. 530 - 1400 mn wavelength is indicated for Fitzpatrick skin tyes I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles) * Benign cutaneous lesions including warts, scars, and striae 560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae 585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae 640- 1400 rn wavelength is indicated for Fitzpatrick skin types I-IVfor the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction 690 - 1400un wavelength isindicated for Fitzpatrick skin types IV and Vfor the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

Source page: https://510kreport.com/device/K082033
Methodology: https://510kreport.com/methodology