# K090837: Stratapulse TS and Stratapulse

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Photonics
- Decided: Jun 17, 2009 after 82 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 10 generations back to K910422 (1992). 89 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082484: Accelawave System, Genesis Biosystems, Inc. (2008) Summary page 1.

## Most influential descendants
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own
- K220794: 10PL (2022), 0 descendants of its own

## Indications for use
Indications For Use (For Fitzpatrick Skin Types See Indications and Filters vs. Skin Types Chart Below): The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions: · Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen. · Treatment of: o Moderate inflammatory acne vulgaris o Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles). o Cutaneous lesions including scars o Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations. * Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery procedures to: o Reduce pain during light treatment (via partial anesthesia from cooling). o Reduce discomfort during and/or associated with light treatment o Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation. o Allow the use of higher light or laser fluences for light treatments (such as for hair reduction and the treatment of vascular or pigmented lesions) o Reduce potential side effects of light treatment (such as for hair reduction and the treatment of vascular or pigmented lesions)

Source page: https://510kreport.com/device/K090837
Methodology: https://510kreport.com/methodology