# K040055: Polylase LP

- Pathway: 510(k) (Traditional)
- Applicant: Ddc Technologies, Inc.
- Decided: Apr 7, 2004 after 86 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
No predicates in its family tree.
59 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090571: Alma Lasers ALEX755 Module (2009), 58 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K222064: The Alma Soprano Titanium (2022), 14 descendants of its own

## Indications for use
1. The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength. 2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-HIL with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. 3 FOR PHOTOCOAGULATION AND HEMOSTASIS OF DERMATOLOGICAL VASCULAR LESIONS with 1064 nm output wavelength. 4. FOR INCISION/EXCISION OF SOFT BODY TISSUES IN DERMATOLOGY with 1064 nm output wavelength. 5. FOR NONABLATIVE WRINKLE REDUCTION AND SKIN COLLAGEN REJUVENATION with 1064 nm output w,~vel ngt.

Source page: https://510kreport.com/device/K040055
Methodology: https://510kreport.com/methodology