510(k) · Cleared
ClearedAngelite Family of Intense Pulsed Light Systems, Models Angelite-DDC and Angelite-SDC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laser Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 29, 2009 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jan 29, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK083915 Angelite Family of Intense Pulsed Light Systems, Models Angelite-DDC…Advanced Technology Laser Co., Ltd. · 2009
- Descendant · cites it directly · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK102857 Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK181868 SHINY RPL SystemIds, Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK220794 10PLTentech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK101901 Ipl Therapy SystemBeijing Starlight Science & Technology Development · 2011
Most influential descendants
Showing 5 of 5 · See all- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · cites it directly4descendants
- K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd. · 2011 · 2 generations on2descendants
- K181868SHINY RPL SystemIds, Ltd. · 2018 · 3 generations on1descendant
- K22079410PLTentech Co., Ltd. · 2022 · 3 generations on0descendants
- K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083915 | Angelite Family of Intense Pulsed Light Systems, Models Angelite-DDC and… | Advanced Technology Laser Co., Ltd. | 2009 | — |
| +1 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
| +2 | K102857 | Ahwon's Ipl System | Ahwon Medi Instrument Co., Ltd. | 2011 | — |
| +3 | K181868 | SHINY RPL System | Ids, Ltd. | 2018 | — |
| +3 | K220794 | 10PL | Tentech Co., Ltd. | 2022 | — |
| +1 | K101901 | Ipl Therapy System | Beijing Starlight Science & Technology Development | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091664 (Shenzhen Gsd Tech Co., Ltd., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow: 1. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of inflammatory acne. 2.…
Read the full statement (148 words)
The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:
1. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of inflammatory acne.
2. Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of benign (epidermal and coetaneous) lesions including warts, scars and striae. 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, facial veins and venous malformations.
3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of unwanted hair (i.e., hair removal).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083915: Angelite Family of Intense Pulsed Light Systems, Models Angelite-DDC and Angelite-SDC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083915
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026