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Apolomed document library

Certifications &
510(k) clearances.

Explore the records behind our technology. Find device-specific FDA clearances, quality-system documentation, and materials-testing records in one place.

Explore all documents FDA records reviewed September 13, 2026
5Quality & company documents
TÜV, ISO 13485, MDSAP & D-U-N-S
6RoHS documents
Materials testing & assessments
15FDA 510(k) records
Including two clearances in 2026

United States · Device records

FDA 510(k) clearances

Browse by device name, year, or K-number. Each entry links to the FDA record and its published decision letter or summary.

A 510(k) clearance applies to the device and indications identified in that record. It is not an endorsement of the company or every product in the portfolio.

K0936272011
K093627 — IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 documentView document

Cleared

IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650

Historical IPL record. The FDA summary names PATS Corp. as the original applicant and Shanghai Apolo as manufacturer.

FDA record Official PDF

TÜV · ISO 13485 · MDSAP · D-U-N-S

Quality certifications & company documents

Published TÜV, ISO 13485, MDSAP, and business-registration documents. Open each document to review its entity, scope, and stated dates.

MDR transition confirmation is not an MDR certificate. D-U-N-S registration is a business identifier, not a medical-device clearance.

Materials documentation

RoHS testing & assessments

Historical published records for the specified samples and device families. These concern restricted substances, rather than clinical performance.

Documents may show past validity periods. Contact Apolomed for the current documentation relevant to your device and market.

Global documentation

Other international

Quality certificates, regional registrations, patent publications, and supporting records for Shanghai Apolo. Each card identifies its document type and source.

ChinaPatent application publication
Semiconductor laser hair-removal device — CN104825227A — original document previewView document

Semiconductor laser hair-removal device — CN104825227A

Publication: 12 August 2015. Intellectual-property record; not a medical-device authorization or a statement of current patent status.

Source record Original document
ChinaPatent application publication
Multifunction laser treatment instrument — CN104491989A — original document previewView document

Multifunction laser treatment instrument — CN104491989A

Publication: 8 April 2015. Intellectual-property record; not a medical-device authorization or a statement of current patent status.

Source record Original document

Regional entries apply to the named devices and sponsors. Patent publications document intellectual property, not medical approval. Historical documents and secondary references are identified individually.

From records to the right questions

Documentation that fits
your device and market.

Our team can help identify the right records for the model, configuration, and region you are evaluating.

Request device documentation
What does an FDA 510(k) clearance mean?

FDA determined that the named device is substantially equivalent to a legally marketed predicate for the indications described in its submission. Review the linked FDA record and labeling for the exact scope.

Does one clearance cover every Apolomed system?

No. Match the device name, model, and configuration to the relevant record. Current regional product names should not be assumed to match a clearance without supporting documentation.

How should I read certificate dates?

The gallery includes historical records. A printed date or expiry is part of that document, rather than confirmation of current status. Ask our team for the latest applicable document before procurement or distribution.

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