Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262524

Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.

Q: How to monitor Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. and peer general & plastic surgery records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.: 510(k) cleared for ONE BEAUTY Technology Co., Ltd. Its amount of 58 is below the median of 138 (15th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 58 · 15th percentile of 414 FDAPulse records · 0.4x the median

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K262524
Device	Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
Applicant	ONE BEAUTY Technology Co., Ltd.
Specialty / panel	General, Plastic Surgery
Product code	OHT
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-07-22
Decision date	2026-09-18
Review time (days)	58
Third-party review	No
Applicant location	Shenzhen, CN
amount percentile	15th of 414 (median 138, 0.4x median)
Peer records CSV (76 CN records)	🔒 Click to unlock →
CRM-ready export with official source URLs	🔒 Click to unlock →

View the official record

Markdown version

Watch Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.

Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.

Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.

Unlock Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co. + all 76 CN records (CSV)

Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL

Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-18
Data refreshed: 2026-11-04
Refunds on request within 14 days

Search all CN records free →

Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →

LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

Is this your business? Add a "Listed on Zalwin" badge to your site

Paste this snippet into your website. It links to this public record; nothing is tracked on your site.

<a href="https://zalwin.com/report/fdapulse/sapphire-cooling-ipl-hair-removal-device-ice-2-0-ice-2-1-cn--k262524" rel="noopener"><img src="https://zalwin.com/badge/listed.svg" alt="Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. on Zalwin public records" width="150" height="28"></a>

Peer benchmark and outreach value: Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. and 76 CN peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

CN FDAPulse records like this one: 76
Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.'s amount: 15th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

30 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 58-day review: this device is a strong predicate for similar products.

What is the FDAPulse record for Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd.?

Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524) by ONE BEAUTY Technology Co., Ltd. was cleared on 2026-09-18 after 58 days of review.

How does Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. compare to other FDAPulse records?

Its amount of 58 is below the median (15th percentile); smaller records often move faster and face less competition. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.

Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524) vs. top 3 peers

Organization	Location	Record date
Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524)	CN	2026-09-18
TECAR Therapy Device (TC2000, TC2001) (K252288)	CN	2026-10-13
easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291)	CN	2026-09-25
Nd	CN	2026-10-13

How to monitor Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. and peer general & plastic surgery records

Get new FDAPulse records like Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) (K262524): 510(k) cleared for ONE BEAUTY Technology Co., Ltd. by email (free, weekly)

We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.

Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.

See this week's digest

Get clearances and recalls like this every day

FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.

See plans

✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

Often used together

Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.