# K093627: Ipulselight Ipl System, Models HS 300C and HS 650

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technologies Co., Ltd.
- Decided: Jan 18, 2011 after 421 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.
24 later devices descend from it; 4 cite it directly.
0 of 114 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 2.

## Most influential descendants
- K122995: Intense Pulsed Light (Ipl) Systems (2013), 16 descendants of its own
- K200746: IPL Treatment Systems (2020), 5 descendants of its own
- K161286: IPL Therapy Machine (2016), 5 descendants of its own
- K192521: Intense Pulsed Light Treatment System (2019), 3 descendants of its own
- K131859: Multifunctional Series (2013), 3 descendants of its own

## Indications for use
iPulseLight IPL System (HS 300C, HS 650) 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: - Moderate inflammatory acne vuigaris - Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles). - Cutaneous lesions including scars - Benign cutaneous vascular lesions including port wine stains, heniangiomnas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins, spider anglomas and venous malformations. The 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. - Reduce pain during light treatment (via partial anesthesia from cooling) - Reduce discomfort during and/or associated with light treatment - Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment. thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation - Allow the use of higher light or laser fluencies for light treatments (such as for hair removal and the treatment of vascular or pigmented lesions) - Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

Source page: https://510kreport.com/device/K093627
Methodology: https://510kreport.com/methodology